NYSW Beverage Brands 1/7/15

Transcription

1 8/26/ > NYSW Beverage Brands 1/7/15 U.S. Food and Drug Administration Protecting and Promoting Your Health NYSW Beverage Brands 1/7/15 SHARE ( U=HTTP%3A%2F%2FWWW.FDA.GOV%2FICECI%2FENFORCEMENTACTIONS%2FWARNINGLETTERS%2F2015%2FUCM HTM) TWEET ( TEXT=NYSW%20BEVERAGE%20BRANDS%201%2F7%2F15&URL=HTTP%3A%2F%2FWWW.FDA.GOV%2FICECI%2FENFORCEMENTACTIONS%2 FWARNINGLETTERS%2F2015%2FUCM HTM) (MAILTO:? SUBJECT=NYSW%20BEVERAGE%20BRANDS%201%2F7%2F15&BODY=HTTP%3A%2F%2FWWW.FDA.GOV%2FICECI%2FENFORCEMENTACTIO NS%2FWARNINGLETTERS%2F2015%2FUCM HTM) Department of Health and Human Services Public Health Service Food and Drug Administration New York District Liberty Avenue Jamaica, NY January 7, 2015 WARNING LETTER NYK VIA OVERNIGHT DELIVERY DELIVERY SIGNATURE REQUESTED Mr. Richard Zakka, President NYSW Beverage Brands, Inc Country Route 3 Halcott Center, NY Dear Mr. Zakka: 1/7

2 8/26/ > NYSW Beverage Brands 1/7/15 On June 4 25, 2014, an investigator with the U.S. Food and Drug Administration (FDA) inspected your facility located at 1458 Country Route 3, Halcott Center, NY. Our inspection of your facility revealed that you failed to comply with the Current Good Manufacturing Practice (CGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, found in Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products including, but not limited to, VBlast Acai Berry, VBlast Wildberry, and VBlast Tropical Punch to be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements. In addition, your VBlast Tropical Punch, VBlast Gator Pit Energy Formula, and VBlast Pomegranate + Cherry, products are misbranded under section 403 of the Act [21 U.S.C. 343] because they do not comply with the FDA s labeling regulations under 21 CFR Part 101. However, this letter should not be interpreted to mean that FDA agrees with the characterization of your VBlast Acai Berry, VBlast Wildberry, VBlast Tropical Punch, VBlast Gator Pit Energy Formula, and VBlast Pomegranate + Cherry products as dietary supplements. In fact, the labels for your VBlast Acai Berry, VBlast Wildberry, VBlast Tropical Punch, VBlast Gator Pit Energy Formula, and VBlast Pomegranate + Cherry products that we collected during our inspection revealed that these products are represented for use [1] as conventional foods. significant part of the entire daily drinking fluid intake of an average person in the United States. Finally, the products are packaged in a similar manner to other beverage products, such as vitamin waters. Section 201(ff)(2) of the Act provides that dietary supplements do not include products represented for use as conventional foods [21 U.S.C. 321(ff)(2)]. If your VBlast Acai Berry, VBlast Wildberry, VBlast Tropical Punch, VBlast Gator Pit Energy Formula, and VBlast Pomegranate + Cherry products are labeled as dietary supplements, they cannot also be represented for use as conventional foods because a product intended for use as a conventional food is not a dietary supplement. Such labeling would misbrand the products within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labeling would be false or misleading. Further, the introduction or delivery for introduction into interstate commerce, or causing thereof, of such misbranded products is The product labels bear Supplement Facts panels, however the words water and punch are used in the statements of identity for the products. In addition, according to your product labels, the 500 ml products are intended to be consumed in a single serving, which makes up a prohibited under section 301(a) of the Act, 21 U.S.C. 331(a). You may find the Act and the FDA s regulations through links on FDA s home page at ( Adulterated Dietary Supplements To the extent you intend to market your products as dietary supplements, specific CGMP violations observed during the inspection include the following: 1. You failed to establish product specifications for each dietary supplement for the identity, purity, strength, and composition of the finished batch of the dietary supplement, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure 2/7

3 8/26/ > NYSW Beverage Brands 1/7/15 the quality of the dietary supplement as required by 21 CFR (e). Specifically, you did not establish specifications for the identity, purity, strength and composition of any of your various flavors of your finished product to ensure that each batch of product contains the levels of vitamins and minerals purported to be present based on the supplement facts information. Once you have established specifications for products that you receive from a supplier for packaging or labeling as a dietary supplement, you must verify that the specifications are met in accordance with 21 CFR and 21 CFR (c), and you must make and keep records of such specifications in accordance with 21 CFR (b)(1). Your response dated June 25, 2014 indicated that you receive the pre batched syrup from your supplier, and provided specification sheets from the supplier. We note that while you do not manufacture the syrup, you are still responsible for establishing specifications for the identity, purity, strength, and composition of the finished batch of the dietary supplement because you are the final product manufacturer. Reliance on the specification sheets provided by your supplier is insufficient to meet these requirements, and as such, your response is inadequate. 2. You failed to establish identity specifications and component specifications that are necessary to ensure specifications for the purity, strength and composition of dietary supplements manufactured using the components are met, as required by 21 CFR (b)(1) and (b)(2). Specifically, your firm failed to establish identity, purity, strength and composition specifications for each of the components you use to manufacture your finished dietary supplement products. Your response dated June 25, 2014 indicated that you receive the pre batched syrup from your supplier and provided specification sheets obtained from the supplier. We note that while you do not manufacture the syrup, you are still responsible for establishing specifications for each component because you are the final product manufacturer. Reliance on the specification sheets provided by your supplier is insufficient to meet these requirements, and as such, your response is inadequate. 3. Your firm failed to establish and follow written procedures for the responsibilities of the quality control operations as required by 21 CFR Furthermore, your quality control personnel failed to ensure that your manufacturing, packaging, labeling, and holding operations ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record, as required by 21 CFR Specifically, your quality control personnel failed to perform the following quality control operations: Approving written procedures, and deviations from or modifications to them, that may affect the identity, purity, strength, or composition of a dietary supplement [21 CFR (a)]; Approving and releasing, or rejecting, each finished batch for distribution, including any reprocessed finished batch [21 CFR (a)(8)]; Material review and disposition decision [21 CFR ]; Reviewing and approving decisions about whether to investigate a product complaint and reviewing and 3/7

4 8/26/ > NYSW Beverage Brands 1/7/15 approving the findings and follow up action of any investigation performed [21 CFR ]; We acknowledge in your response dated June 25, 2014, you indicated that your Manufacturing and Material Flow Charts clearly outline step by step everything necessary for safe and accurate bottling. You also provided production records, a complaint log, and the document on (b)(4). However, because you did not provide documentation to address each of the quality control violations cited above (e.g., disposition decisions), we are unable to evaluate the adequacy of your response. 4. You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of dietary supplement that you manufacture, and for each batch size, to ensure uniformity in the finished batch from batch to batch, as required by 21 CFR (a). Specifically, you do not have MMRs for any of the dietary supplements that you manufacture. Your response dated June 25, 2014 provided Production Records, which included Production Orders that show a Bill of Materials, and indicated that you are weighing the vitamin syrup caps several times per day and recording the information at the QC Release step of the vitamin syrup cap. Your response is inadequate because the Production Records that you provided are not master manufacturing records. 5. Your firm failed to prepare a complete batch production record every time you manufactured a batch of dietary supplements, as required in 21 CFR (b). Specifically, the batch production records for your VBlast Wildberry (Batch # ), VBlast Acai Berry (Batch ), and VBlast Tropical Punch (Batch # ) failed to include the following information for a batch record, as required by 21 CFR : The identity of equipment and processing lines used in producing the batch [21 CFR (b)]; The date and time of maintenance, cleaning, and sanitizing of the equipment and processing lines used in producing the batch, or a cross reference to records, such as individual equipment logs, where this information is retained [21 CFR (c)]; A statement of actual yield and a statement of the percentage of theoretical yield at appropriate phases of processing [21 CFR (f)]; The actual results obtained during any monitoring operations, including weight checks [21 CFR (g)]; The results of any testing or examination performed during the batch production, or a cross reference to such results, including visual inspection and measurements of bottles [21 CFR (h)]; Documentation, at the time of performance, of packaging and labeling operations, including an actual or representative label, or a cross reference to the actual location of the actual or representative label [21 CFR (k)]. We acknowledge in your response dated June 25, 2014, you indicated that the blow molding process does not need to be documented because the finished product is evaluated as a whole during the Retain/Receipt of the bottles. However, because you did not provide documentation of such evaluation, we are unable to evaluate the adequacy of your response. Additionally, your inventory transfer records do not show who performed the 4/7

5 8/26/ > NYSW Beverage Brands 1/7/15 operations. Further, even though you stated that only labels and packaging which are being used on the current Production Order" are being picked for use, you are still required to maintain a representative label for each batch for your production records in accordance with 21 CFR (k)(2). We note that while you referred to a photograph of a designated marked area for the picked labels and packaging, we did not find this photograph in your response. 6. Your firm failed to retain reserve samples for 1 year past the shelf life date or for 2 years from the date of distribution of the last batch of dietary supplements associated with the reserve sample, as required in 21 CFR (b)(3). Specifically, your samples of assembled bottles are only retained for approximately one month. We acknowledge in your response dated June 25, 2014, you indicated that you will begin retaining (b)(4) bottles from each batch. However, your response is inadequate because you failed to provide information regarding how long you plan to retain these samples. 7. Your firm failed to make and keep a written record of the findings of the investigation and follow up action taken when an investigation is performed, as required by 21 CFR (b)(2)(ii)(F). Specifically, on June 25, 2014, you provided a copy of your (b)(4), but it failed to document the quality control decision to install a (b)(4) to your water treatment regimen to address product complaints relating to particulates found in your bottled water products. 8. Your firm failed to make and keep documentation of training, including the date of the training, the type of training, and the person(s) trained, as required under 21 CFR (b)(2). Specifically, you told our investigator that your employees are trained on the job by your Plant Manager, but this training is not documented. We acknowledge in your response dated June 25, 2014, you indicated that you intend to document training in the future. However, we cannot assess the adequacy of your response because you failed to provide any supporting documentation. Misbranded Dietary Supplements Your VBlast Tropical Punch, VBlast Gator Pit Energy Formula, and VBlast Pomegranate + Cherry, products are misbranded under section 403 of the Act [21 U.S.C. 343] because they do not comply with the FDA s labeling regulations under 21 CFR Part 101: 1. Your VBlast Tropical Punch, VBlast Gator Pit Energy Formula, and VBlast Pomegranate + Cherry products are misbranded under section 403(s)(2)(B) of the Act [21 U.S.C. 343(s)(2)(B)] in that the products do not include a statement of identity as a dietary supplement as required by 21 CFR 101.3(g). 2. Your VBlast Tropical Punch, VBlast Gator Pit Energy Formula, and VBlast Pomegranate + Cherry products are misbranded within the meaning of section 403(k) of the Act [21 U.S.C. 343(k)] because the 5/7

6 8/26/ > NYSW Beverage Brands 1/7/15 products contain an artificial flavoring, coloring, or chemical preservative but do not bear labeling stating that fact. Specifically, Your VBlast Tropical Punch fails to declare fruit juice concentrate (color) and caramel color in the product statement of ingredients. In accordance with 21 CFR (k), the label of a food to which coloring has been added shall declare the coloring in the statement of ingredients. Your VBlast Gator Pit Energy Formula product contains the chemical preservatives propylene glycol and Calcium Disodium Salt of EDTA (sequestrant), however it fails to bear labeling stating that fact in accordance with 21 CFR (j). Your VBlast Tropical Punch and VBlast Pomegranate + Cherry products contain the chemical preservative propylene glycol, however they fail to bear labeling stating that fact in accordance with 21 CFR (j). In accordance with 21 CFR (j), a food to which a chemical preservative is added must bear a label declaration stating both the common or usual name of the ingredient and a separate description of its function. The following product labels fail to list the function of the chemical preservative ingredients: Your VBlast Tropical Punch product label fails to list the function of the ingredient, sodium hexametaphosphate. Your VBlast Gator Pit Energy Formula product label fails to list the function of the ingredients, sodium hexametaphosphate, sodium benzoate, and potassium sorbate. Your VBlast Pomegranate + Cherry product label fails to list the function of the ingredient sodium hexametaphosphate. 3. Your VBlast Gator Pit Energy Formula product is misbranded under section 403(i)(2) of the Act [21 U.S.C. 343(i)(2)] because it is fabricated from two or more ingredients and the label fails to declare an appropriate common or usual name of each ingredient, in accordance with 21 CFR and 21 CFR Specifically, the ingredient statement provided by your supplier listed the sub ingredients DL alpha tocopheryl acetate and Vitamin A Palmitate, however they are not declared on the finished product label. The violations cited in this letter are not intended to be an all inclusive statement of violations that exist at your facility or in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence and the occurrence of other violations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in enforcement action without further notice including, without limitation, seizure and/or injunction. Section 743 of the Act (21 U.S.C. 379j 31) authorizes FDA to assess and collect fees to cover FDA s costs for certain activities, including reinspection related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified non compliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection related costs means all expenses, including administrative expenses, incurred in connection with FDA s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees (21 U.S.C. 379j 31(a)(2)(B)). For a domestic facility, FDA will assess and collect fees for reinspection related costs from the 6/7

7 8/26/ > NYSW Beverage Brands 1/7/15 responsible party for the domestic facility. The inspection noted in this letter identified non compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection related costs. Please respond to this letter in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific steps you are taking to correct the violations listed above and to prevent similar violations in the future. Your response should include any documentation necessary that would assist us in evaluating your corrections. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the date by which you will have completed the correction. Your written response should be sent to Lillian C. Aveta, Compliance Officer, U.S. Food and Drug Administration, Liberty Avenue, Jamaica, New York If you have any questions about this letter, please contact Compliance Officer Lillian C. Aveta at (718) or at Lillian.Aveta@fda.hhs.gov (mailto:lillian.aveta@fda.hhs.gov). Sincerely yours, /S/ Ronald M. Pace District Director New York District [1] See Guidance for Industry: Distinguishing Liquid Dietary Supplements from Beverages, available at ( Follow FDA ( (/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm) Follow FDA ( (/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm) More in 2015 (/ICECI/EnforcementActions/WarningLetters/2015/default.htm) 7/7

8 8/26/ > Complete H2O Minerals 1/8/15 U.S. Food and Drug Administration Protecting and Promoting Your Health Complete H2O Minerals 1/8/15 SHARE ( U=HTTP%3A%2F%2FWWW.FDA.GOV%2FICECI%2FENFORCEMENTACTIONS%2FWARNINGLETTERS%2F2015%2FUCM HTM) TWEET ( TEXT=COMPLETE%20H2O%20MINERALS%201%2F8%2F15&URL=HTTP%3A%2F%2FWWW.FDA.GOV%2FICECI%2FENFORCEM ENTACTIONS%2FWARNINGLETTERS%2F2015%2FUCM HTM) (MAILTO:? SUBJECT=COMPLETE%20H2O%20MINERALS%201%2F8%2F15&BODY=HTTP%3A%2F%2FWWW.FDA.GOV%2FICECI%2FENFO RCEMENTACTIONS%2FWARNINGLETTERS%2F2015%2FUCM HTM) Department of Health and Human Services Public Health Service Food and Drug Administration Atlanta District Office 60 Eighth Street N.E. Atlanta, GA VIA UPS January 8, 2015 Leslie C. Marchant, Owner Lonnie Birmingham, Owner Complete H2O Minerals 707 Greenwood Road West Columbia, SC WARNING LETTER (15 ATL 05) 1/9

9 8/26/ > Complete H2O Minerals 1/8/15 Dear Mr. Marchant and Mr. Birmingham: From June 3 through June 5, 2014, the U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement manufacturing facility located at 707 Greenwood Road in West Columbia, SC. Based on the inspection and review of the product labels you provided during the inspection, we have found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA s website at ( Unapproved Drugs/Misbranded Drugs Based on our review of your products labeling, we have determined that several of your firm s dietary supplements are being promoted for conditions that cause them to be drugs within the meaning of Section 201(g)(1)(B) of the Act [21 United States Code (U.S.C.) 321(g)(1)(B)]. The claims made on your products labeling establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. The claims observed on your products labeling include, but are not limited to, the following: Sulfur Concentrate, 128 ounces and 32 ounce [V]ital for repair of blood vessels, bones, gums, body cells and teeth most important health role is in carbohydrate metabolism, which is critical for hypoglycemic and diabetics Extra Strength Copper, 32 ounce [I]s known to be antiparasitic Copper, 32 ounce and 2 ounce [I]s known to be antiparasitic Extra Strength Magnesium, 32 ounce [W]as shown to reduce the risk of diabetes. It was also shown to lower the risk of osteoporosis Extra Strength Silver, 32 ounce [I]s antibacterial, antiviral, and antifungal 2/9

10 8/26/ > Complete H2O Minerals 1/8/15 Silver, 32 ounce [I]s antibacterial, antiviral, and antifungal Platinum, 32 ounce [M]ay be effective in conjunction with cancer treatments Gold, 32 ounce [R]eported to be effective against active joint inflammation is not analgesic but may have anti inflammatory effects Extra Strength Zinc, 32 ounce [V]ital for wound healing from surgery and tissue repair following radiation/chemotherapy Zinc, 32 ounce [V]ital for wound healing from surgery and tissue repair following radiation/chemotherapy Chromium, 32 ounce and 2 ounce [C]hromium may also be effective in alleviating elevated blood sugar levels (hyperglycemia) Indium, 32 ounce [I]ndium can also lower blood pressure Molybdenum, 32 ounce [I]s known to fight cavities as well Sodium, 2 ounce [D]emonstrated to attenuate nitric oxide production. Nitric oxide (NO) contributes to vessel homeostasis by inhibiting platelet aggregation Cesium, 2 ounce [I]nduce long term narrowing of the blood vessels (vasoconstriction) and the associated increase in the blood pressure (hypertension) Calcium Concentrate, 32 ounce Calcium [an ingredient in this product] is essential for the prevention of osteoporosis in postmenopausal women. 3/9

11 8/26/ > Complete H2O Minerals 1/8/15 Extra Strength Calcium Concentrate, 32 ounce Calcium [an ingredient in this product] is essential for the prevention of osteoporosis in postmenopausal women. B6 & B12 Folic Acid, 4 ounce Vitamin B 6 [an ingredient in this product] has a role in preventing heart disease. Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, are new drugs under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. 355(a)]; see also section 301(d) of the Act [21 U.S.C. 331 (d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Furthermore, your Sulfur Concentrate, 128 ounce and 32 ounce; Extra Strength Copper, 32 ounce; Copper, 32 ounce and 2 ounce; Extra Strength Magnesium, 32 ounce; Extra Strength Silver, 32 ounce; Silver, 32 ounce; Platinum, 32 ounce; Extra Strength Zinc, 32 ounce; Zinc, 32 ounce; Chromium, 32 ounce and 2 ounce; Indium, 32 ounce; Sodium, 2 ounce; Cesium, 2 ounce; Calcium Concentrate, 32 ounce; Extra Strength Calcium Concentrate, 32 ounce; and B6 & B12 Folic Acid, 4 ounce, products are offered for conditions that are not amenable to self diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, these drugs are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)], in that the labeling fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of Section 301(a) of the Act [21 U.S.C. 331(a)]. Adulterated Dietary Supplements In addition, even if your products were not labeled for conditions that cause them to be unapproved new and misbranded drugs, your products would be adulterated dietary supplements within the meaning of Section 402(g)(1) of the Act [21 U.S.C. 342(g)(1)] because they have been prepared, packed, or held under conditions that do not meet the current good manufacturing practice regulation for dietary supplements found in Title 21 Code of Federal Regulations, Part 111 (21 CFR 111). At the close of our inspection, you were advised of these issues in the issued Form FD 483, Inspectional Observations. Our inspection revealed the following violations: 4/9

12 8/26/ > Complete H2O Minerals 1/8/15 1 You failed to establish product specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement you manufacture, and specifications for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR (e). Specifically, you told our investigator that you manufacture the finished product strength of your products to the value declared on the label for the active ingredient; however, you do not have written finished product specifications for each dietary supplement you manufacture for identity, purity, and composition. Once you establish product specifications for the identity, purity, strength, and composition of the finished batch of each dietary supplement you manufacture, and specifications for limits on those types of contamination that may adulterate, or that may lead to adulteration of, the finished batch of the dietary supplement, it is your responsibility to ensure that your product meets these specifications (21 CFR ). 2 You failed to prepare and follow a written master manufacturing record (MMR) for each unique formulation of a dietary supplement that you manufacture, as required by 21 CFR (a). Specifically, when our investigator asked your firm for master manufacturing records, you stated that you do not have them. In addition, we note that an MMR must include certain information, as specified in 21 CFR You failed to prepare a batch production record every time you manufacture a batch of a dietary supplement, as required by 21 CFR (a). Specifically, you verbally confirmed to our investigator that you did not maintain batch production records. In addition, we note that a batch production record must include certain information, as specified in 21 CFR You failed to establish and follow written procedures for the responsibilities of the quality control operations, including written procedures for conducting a material review and making a disposition decision, and for approving or rejecting any reprocessing, as required by 21 CFR Specifically, you verbally confirmed to our investigator that you did not maintain these procedures. Moreover, our investigator observed that records, including but not limited to, your production records and ingredient receiving records, do not have a QC review signature on them, as required by 21 CFR You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR (a). Specifically, you verbally confirmed to our investigator that you do not collect and hold reserve samples for each lot of packaged and labeled dietary supplements that you distribute. In addition we note that reserve samples must be maintained in accordance with certain criteria, as specified in 21 CFR (b). 5/9

13 8/26/ > Complete H2O Minerals 1/8/15 6. You failed to identify each unique lot within each unique shipment of components that you receive and any lot of components that you produce in a manner that allows you to trace the lot to the supplier, the date received, the name of the component, the status of the component (e.g., quarantined, approved, or rejected); and to the dietary supplement you manufactured and distributed, as required by 21 CFR (d)(1). Specifically, you verbally confirmed that you do not record any kind of unique lot identified for incoming components nor the lot number assigned by the supplier of the components. Further you confirmed that you have no means to identify which specific lot of component was used to manufacture any specific lot of finished product. In addition, we note that you must use this unique identifier whenever you record the disposition of each unique lot within each unique shipment of components that you receive and any lot of components that you produce, as required by 21 CFR (d)(2). 7. You failed to identify each unique lot within each unique shipment of packaging and labels in a manner that allows you to trace the lot to the supplier, the date received, the name of the packaging and label, the status of the packaging and label (e.g., quarantined, approved, or rejected); and to the dietary supplement that you distributed, as required by 21 CFR (d) (1). Specifically, you verbally confirmed that you do not record any kind of unique lot identified for incoming components nor the lot number assigned by the supplier of the components. Further you confirmed that you have no means to identify which specific lot of component was used to manufacture any specific lot of finished product. In addition, we note that you must use this unique identifier whenever you record the disposition of each unique lot within each unique shipment of packaging and labels, as required by 21 CFR (d)(2). 8. You failed to establish and follow written procedures for laboratory operations, including written procedures for the tests and examinations that you conduct to determine whether specifications are met, as required by 21 CFR Specifically, you verbally confirmed that you test every batch of product produced using an atomic (b)(4) with the results compared to a standard. However, you stated that the procedure used to perform this test is not a written procedure. At the close of the inspection, you indicated that you would provide a written response to the FORM FDA 483, Inspectional Observations, issued to you. To date, we have not received that written response. In addition, your Ultimate Germanium Concentrate, 2 ounce, and Germanium Concentrate, 32 ounce, dietary supplements are adulterated within the meaning of Section 402(a)(1) [21 U.S. C. 342(a)(1) of the Act in that they bear or contain a poisonous or deleterious substance which may render these products injurious to health. Germanium is a nonessential trace element that has 6/9

14 8/26/ > Complete H2O Minerals 1/8/15 caused nephrotoxicity (kidney injury) and death when used chronically by humans, even at recommended levels of use. Due to the risk of illness or injury associated with germanium, we recommend that your firm cease the manufacture and marketing of your product containing this ingredient. Misbranded Dietary Supplements 1. Your Extra Strength Calcium concentrate (32 ounce) and Extra Strength Silver Concentrate (32 ounce) products are misbranded within the meaning of section 403(a)(1) of the Act [21 U.S.C. 343(a)(1)] in that the labels of these products are false and misleading because the amount of certain ingredients in these products does not match the level of those ingredients declared on the products label. Specifically: Your Extra Strength Calcium Concentrate (32 ounce) label lists the level of Chloride in the product as 184 mg and shows that the Chloride ingredient is at 6800 ppm (or 6.79 mg/ml). For a serving size of 15 ml, this results in a level of about 102 mg/serving. Your Extra Strength Silver Concentrate (32 ounce) label lists the level of Nitrates in the product as mg and shows that the Nitrate ingredient is at 400ppm (or 0.4 mg/ml). For a serving size of 5 ml, this results in a level of 2 mg/serving. 2. Your Sulfur Concentrate (128 ounces and 32 ounce), Extra Strength Calcium Concentrate (32 ounce), Calcium Concentrate (32 ounce), Ultimate Calcium Concentrate (2 ounce), Extra Strength Copper Concentrate (32 ounce), Copper Concentrate (32 ounce), Ultimate Copper Concentrate (2 ounce), Extra Strength Magnesium Concentrate (32 ounce), Ultimate Magnesium Concentrate (2 ounce), Extra Strength Silver Concentrate (32 ounce), Silver Concentrate (32 ounce), Platinum Concentrate (32 ounce), and Gold Concentrate (32 ounce) products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C 343(q)(5)(F)] in that the labels of these products fail to comply with 21 CFR (b)(2)(i). Specifically, these products declare (b)(2) dietary ingredients, such as Calories, Total Fat and Total Carbohydrates, as zero when these (b)(2) dietary ingredients must not be declared on the label when they are not present or are present in amounts that can be declared as zero under 21 CFR 101.9(c). This letter is not intended to be an all inclusive list of violations that may exist at your facility. It is your responsibility to ensure that the products you manufacture are in compliance with all requirements of the Act and pertinent FDA regulations, such as the dietary supplement regulations (21 CFR Part 111). You can find copies of the Act and pertinent regulations through links on FDA s homepage at ( You should take prompt action to correct all of the violations noted in this letter and establish and implement procedures that will prevent these and other violations in the future. Failure to implement lasting corrective actions may result in FDA 7/9

15 8/26/ > Complete H2O Minerals 1/8/15 taking regulatory action, such as seizure or injunction, without further notice. We also offer the following comments: You do not collect any representative samples from each unique lot of components, packaging, and labels that you use to determine whether the components, packaging, and labels meet established specifications, as required by 21 CFR (a). These samples are not required to be maintained once testing is complete, but they must be collected from each unique lot of components, packaging, and labels which you receive. The label for your Sulfur Concentrate, (128 ounces and 32 ounce) lists Chloride with a value of zero. This is a voluntary nutrient for declaration under 21 CFR 101.9(c)(8)(ii), and therefore, can be omitted if it is not present in the product. Section 743 of the Act [21 U.S.C. 379j 31] authorizes FDA to assess and collect fees to cover FDA s costs for certain activities, including reinspection related costs. A reinspection is one or more inspections conducted subsequent to an inspection that identified noncompliance materially related to a food safety requirement of the Act, specifically to determine whether compliance has been achieved. Reinspection related costs means all expenses, including administrative expenses incurred in connection with FDA s arranging, conducting, and evaluating the results of the reinspection and assessing and collecting the reinspection fees [21 U.S.C. 379j 31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for reinspection related costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any reinspection related costs. Please respond to this office in writing within fifteen (15) working days from your receipt of this letter. In your response, identify the steps you have taken or will take to correct the above noted violations and prevent similar ones. Please include the timeframe in which the corrections will be completed and provide any documentation that will effectively assist us in evaluating whether the corrective actions have been made and the adequacy of such. If you are unable to complete the corrective actions within fifteen (15) working days, identify the reason for the delay and the time within which you will complete the corrections. Your written response should be sent to the U.S. Food and Drug Administration, Attn: Lakisha N. Morton, Compliance Officer, at the address noted in the letterhead. If you have questions, please contact Mrs. Morton at or write her at the noted address. 8/9

16 8/26/ > Complete H2O Minerals 1/8/15 Sincerely, /S/ Ingrid Zambrana District Director, Atlanta Office Follow FDA ( (/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm) Follow FDA ( (/AboutFDA/AboutThisWebsite/WebsitePolicies/Disclaimers/default.htm) More in 2015 (/ICECI/EnforcementActions/WarningLetters/2015/default.htm) 9/9

17 8/26/ > Fragrance Manufacturing, Inc. D/b/a FMI 1/21/15 U.S. Food and Drug Administration Protecting and Promoting Your Health Fragrance Manufacturing, Inc. D/b/a FMI 1/21/15 SHARE ( U=HTTP%3A%2F%2FWWW.FDA.GOV%2FICECI%2FENFORCEMENTACTIONS%2FWARNINGLETTERS%2F2015%2FUCM HTM) TWEET ( TEXT=FRAGRANCE%20MANUFACTURING%2C%20INC.%20D%2FB%2FA%20FMI%201%2F21%2F15&URL=HTTP%3A%2F%2FW WW.FDA.GOV%2FICECI%2FENFORCEMENTACTIONS%2FWARNINGLETTERS%2F2015%2FUCM HTM) (MAILTO:? SUBJECT=FRAGRANCE%20MANUFACTURING%2C%20INC.%20D%2FB%2FA%20FMI%201%2F21%2F15&BODY=HTTP%3A%2F %2FWWW.FDA.GOV%2FICECI%2FENFORCEMENTACTIONS%2FWARNINGLETTERS%2F2015%2FUCM HTM) Department of Health and Human Services Public Health Service Food and Drug Administration PHILADELPHIA DISTRICT 900 U.S. Customhouse 2nd and Chestnut Streets Philadelphia, PA Telephone: WARNING LETTER 15 PHI 10 CERTIFIED MAIL RETURN RECEIPT REQUESTED 1/7

18 8/26/ > Fragrance Manufacturing, Inc. D/b/a FMI 1/21/15 January 21, 2015 Mr. Kevin H. Rhodes, CEO Fragrance Manufacturing Incorporated DBA FMI 100 Cascade Drive Allentown, PA Dear Mr. Rhodes: The U.S. Food and Drug Administration (FDA) inspected your manufacturing facility located at 100 Cascade Drive, Allentown, PA on March 20, 2014 through April 2, 2014, during which we collected product labeling. Based on the inspection and our review of your product labeling, we found serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. You may find the Act and FDA regulations through links on FDA s home page at ( We received your letter, dated April 21, 2014, responding to the form FDA 483, Inspectional Observations that we issued on April 2, We have reviewed your responses as further discussed in this letter. Unapproved New Drugs Based on our review of your Maty s All Natural Cough Syrup and Maty s All Natural Cough Syrup for Kids product labeling, we have determined that your products are being promoted for conditions that cause them to be drugs within the meaning of Section 201(g)(1)(B) of the Act [21 U.S.C. 321(g)(1)(B)]. The therapeutic claims made on your products labels establish that the products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. Specifically, the names of your Maty s All Natural Cough Syrup and Maty s All Natural Cough Syrup for Kids products cause the products to be drugs. Your Maty s All Natural Cough Syrup and Maty s All Natural Cough Syrup for Kids products are not generally recognized as safe and effective and, therefore, are new drugs under section 201(p) of 2/7

19 8/26/ > Fragrance Manufacturing, Inc. D/b/a FMI 1/21/15 the Act [21 U.S.C. 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the Act [21 U.S.C. 355(a)]; see also section 301(d) of the Act [21 U.S.C. 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Dietary Supplement CGMP Violations Even if the labeling for your Maty s All Natural Cough Syrup and Maty s All Natural Cough Syrup for Kids products did not make therapeutic claims, which make the products unapproved new drugs, these products would still be adulterated within the meaning of section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. 342(g)(1), in that they have been prepared, packed, or held under conditions that do not meet Current Good Manufacturing (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). Specifically, the inspection revealed the following significant violations of the CGMP regulations for dietary supplements: 1. You failed to establish product specifications for the identity, purity, strength, and composition of the finished batches of your dietary supplements, and for limits on those types of contamination that may adulterate, or that may lead to adulteration of the finished batches of your dietary supplements as required by 21 CFR (e). Specifically, You failed to establish a specification for percent strength of zinc gluconate for finished batches of Maty s All Natural Cough Syrup and Maty s All Natural Cough Syrup Kids products You have not established a finished product specification limit for yeast and mold plate counts. In your response, you indicate that you have developed a specification for the zinc gluconate content for this product that will be made part of its release criteria. However, we cannot assess the adequacy of your response because you did not provide documentation to demonstrate your newly established specification for zinc gluconate. You also indicate that although yeast and mold plate counts were not listed in the finished product specification, testing was conducted and reviewed before releasing the product. Furthermore, you state that effective immediately, the specification of (b)(4) are established, and further identification testing will be conducted on batches that have a result higher than the specification before determining the disposition of that batch. However, we cannot assess the adequacy of your response because you lack documentation to demonstrate the limits established by your firm to 3/7

20 8/26/ > Fragrance Manufacturing, Inc. D/b/a FMI 1/21/15 ensure the quality of the dietary supplements. 2. You failed to provide adequate documentation of your basis for determining that compliance with specifications you selected will ensure that your finished batch of the dietary supplement meets all product specifications for the limits on those types of contamination that may adulterate, or that may lead to adulteration of, the dietary supplement as required by 21 CFR (c)(3). Specifically, you lack adequate documentation and/or scientific rationale that demonstrates that your established specification for microbial limits used in the manufacture of Maty s All Natural Cough Syrup and Maty s All Natural Cough for Kids will ensure that your finished batch will not be adulterated as a result of such contamination. We have reviewed your response letter, dated April 21, 2014, and have determined that we cannot assess the adequacy of your response. You do not provide documentation for your basis for determining that there are no harmful micro organisms in your product. You state in your response letter The primary ingredient in the Maty's Cough Syrups is honey which can contain naturally occurring, non harmful micro organisms. You also state Beginning immediately, we are lowering the specifications for acceptable to (b)(4) However, you do not provide adequate documentation for your basis of setting the safe level of microorganism in your product at (b)(4). In addition, you do not provide the type of microorganism or the method you are using to test for them. In addition, we note your dietary supplement products contain other components which may have contaminants or impurities. You do not provide documentation to demonstrate that such contaminants or impurities are absent from your product. For example, you do not provide evidence that the distilled water you use is safe and of adequate sanitary quality. 3. You did not make and keep documentation, in individual equipment logs, of the date of the use, maintenance, cleaning, and sanitizing of equipment, as required by 21 CFR (b)(2). Specifically, Since June 12, 2012, (b)(4) lots of cough syrup products were manufactured, and a total of (b) (4) of the (b)(4) lots were not listed in the cleaning and use log. In addition, the equipment used to produce the cough syrup is shared for filling of home care products. As a result, it cannot be determined if cleaning was performed prior to production of each batch or what products were produced on the equipment prior to filling of your cough syrup products. In your response, you indicated that multiple lots of cough syrup were run immediately after each other, i.e. (b)(4) of the (b)(4) lots. You also stated that you have conducted in depth training on the correct procedure to document the use, cleaning and sanitizing of the equipment with all appropriate personnel. However, we cannot assess the adequacy of this response because it does 4/7

21 8/26/ > Fragrance Manufacturing, Inc. D/b/a FMI 1/21/15 not include documentation to demonstrate sequential production of the above product or implementation of your corrective actions. 4. Your quality control operations did not determine whether each finished batch conforms to product specifications established in accordance with 21 CFR (e), as required by 21 CFR (a)(7). Specifically, your quality control personnel failed to conduct a review to ensure that the finished product batches of your cough syrup products met specifications prior to release and distribution. In your response, you state that you have established a protocol that has a centralized document where all relevant testing results are compiled and reviewed for each FDA regulated product. This document will serve as the final review of results and will subsequently be assigned the acceptance or rejection disposition. Upon the product meeting the specified criteria, this document will be signed off as approval for release of the batch. The adequacy of your response will be assessed during future inspections. The above violations are not intended to be an all inclusive list of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in FDA taking regulatory action without further notice, including, without limitation, injunction or seizure. During the inspection, our investigator also observed deviations from current good manufacturing practice (CGMP) regulations in the manufacture of drug products at your facility. As a manufacturer of human drugs it is your responsibility to assure that any drug products produced are manufactured in conformance with CGMP as delineated in 21 CFR parts 210 and 211. For example, your firm failed to establish adequate written procedures for cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing, of holding of a drug product, as required by 21 CFR (b ), in that your firm has not validated the effectiveness of the cleaning procedures used. In addition, your firm failed to establish adequate written procedures for production and process control, as required by 21 CFR (a), in that none of the manufacturing processes for drug products have been validated to demonstrate that they can produce drug products that consistently have the identity, strength, quality and purity they purport or are represented to possess. Also, your firm has not demonstrated that the equipment 5/7