Optimum Bioenergy International Corp. 12/21/17

Transcription

1 Optimum Bioenergy International Corp. 12/21/17 Office of Human and Animal Food Division 5 West 1431 Harbor Bay Parkway Alameda, CA Sent Via UPS Signature Required WARNING LETTER December 21, 2017 Mr. Louise KC Li, Owner Optimum Bioenergy, Intl Pomona Road Corona, CA Reference FEI# /Case # Dear Mr. Louise KC Li: The United States Food and Drug Administration (FDA) inspected your dietary supplement manufacturing facility located at 2463 Pomona Road, Corona, CA from June 6, 8-9, 16, During our inspection, FDA investigators observed serious violations of the FDA s regulations for in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, under Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). The violations cause your dietary supplement products identified below 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 the products have been prepared, packed, or held under conditions that do not meet cgmp requirements for dietary supplements. In addition, FDA reviewed the labels for your EssenceLife Bee Propolis, Youth Life L-Carnitine, Youth Life Collagen and Youth Life Calcium products and determined they are misbranded within the meaning of section 403 of the Act [21 U.S.C. 343] as detailed below. You can find the Act and FDA regulations through links on FDA s website at (

2 We have received your written response dated July 7, 2017, concerning our investigator s observations noted on the FDA-483, Inspectional Observations, which was issued to you on June 16, Our comments regarding the adequacy of the actions you took to correct the objectionable conditions and practices observed during the inspection are detailed after the applicable violations, noted below. Your significant violations are as follows: 1. 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, during the inspection our investigator observed that that you did not have any written procedures for the responsibilities of quality control operations. Once you have established your quality control written procedures, you must implement them into your manufacturing, packaging, labeling and holding operations, as required by 21 CFR and you must implement a system of production and process controls that covers all stages of manufacturing, packaging labeling, and holding to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in a master manufacturing record, as required by 21 CFR The quality control personnel must ensure that the 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 Furthermore, you must have documentation of the quality control personnel s review and approval of release for any packaged and labeled dietary supplement for distribution, as required by 21 CFR (h) and (b) (2). We have reviewed your response letter, dated July 7, 2017; however, we are unable to evaluate the adequacy of your response because you have not provided any written procedures for the responsibilities of the quality control operations. As a distributor that contracts with other manufacturers to manufacture and package dietary supplements that your firm releases for distribution under your firm s name, your firm has an obligation to know what and how manufacturing activities are performed so that you can make decisions related to whether your dietary supplement products conform to established specifications and whether to approve and release the products for distribution [72 Fed. Reg , (Jun. 25, 2007)]. Your firm introduces or delivers, or causes the introduction or delivery, of the dietary supplement into interstate commerce in its final form for distribution to consumers. As such, your firm has an overarching and ultimate responsibility to ensure that all phases of the production of that product are in compliance with dietary supplement CGMP requirements. Although your firm may contract out certain dietary supplement manufacturing operations, it cannot by the same token, contract out its ultimate responsibility to ensure that the dietary supplement it places into commerce (or causes to be placed into commerce) is not adulterated for failure to comply with dietary supplement CGMP requirements (see United States v. Dotterweich, 320 U.S. 277, 284 (1983) (explaining that an offense can be committed under the Act by anyone who has a responsible share in the furtherance of the transaction which the statute outlaws ); United States

3 v. Park, 421 U.S. 658, 672 (1975) (holding that criminal liability under the Act does not turn on awareness of wrongdoing, and that agents vested with the responsibility, and power commensurate with that responsibility, to devise whatever measures are necessary to ensure compliance with the Act can be held accountable for violations of the Act). In particular, the Act prohibits a person from introducing or delivering for introduction, or causing the delivery or introduction, into interstate commerce a dietary supplement that is adulterated under section 402 (g) for failure to comply with dietary supplement CGMP requirements (see 21 U.S.C. 342(g), 331(a)). Thus a firm that contracts with other firms to conduct certain dietary supplement manufacturing, packaging, and labeling operations is responsible for ensuring that the dietary supplement is not adulterated for failure to comply with dietary supplement CGMP requirements, regardless of who actually performs the dietary supplement CGMP operations. 2. You failed to establish specifications for each dietary supplement that you manufacture for the identity, purity, strength, and composition of the finished batch of the dietary supplement, as required by 21 CFR (e). Specifically, the documents you provided for Youth Life L-Carnitine and Youth Life Calcium products did not include a specification for the identity of your finished products. Once you have established finished product specifications, you must determine that the specifications have been met in accordance with d 21 CFR (c), and you must make and keep records for established specifications in accordance with 21 CFR (b)(1). adequacy of your response because you have not provided any specifications for the identity of your finished dietary supplement products. 3. 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 perform labeling of the Bee Propolis product; however, it was observed during the inspection that you do not maintain batch production records for your EssenceLife Bee Propolis product. We acknowledge your response, dated July 7, 2017; however, we find your response to be inadequate because you failed to provide batch production records for your labeling operation for the EssenceLife Bee Propolis product. 4. You failed to prepare and follow a written master manufacturing record 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, it was observed during the inspection that you do not have a master manufacturing record for the labeling of your EssenceLife Bee Propolis product. We acknowledge your response, dated July 7, 2017; however, we find your response to be inadequate in that you did not provide a master manufacturing record for the labeling of your EssenceLife Bee Propolis dietary supplement product. We acknowledge your response, dated July 7, 2017, in which you provided master manufacturing records for Packaging Operation and Coating Operation. However, the master manufacturing records provided do not meet the requirements of 21 CFR For example, among other requirements, your master manufacturing records do not include specifications for each point, step, or stage in the manufacturing process where control is necessary to ensure the quality of the dietary supplement and labeled as specified in the master manufacturing record, as required by 21 CFR (h)(1).

4 5. You failed to establish and follow written procedures to fulfill the requirements related to returned dietary supplements, as required by 21 CFR Specifically, you do not have written procedures for returned dietary supplements. 6. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR Specifically, you do not have written procedures for holding and distributing any of your dietary supplement products. adequacy of your response because you did not provide documentation of your written procedures for holding and distributing operation for your dietary supplement products. 7. You failed to establish and follow written procedures for cleaning the physical plant and for pest control, as required by 21 CFR Specifically, your firm does not have written pest control procedures for the interior of the facility or maintain records to show monitoring for pests are performed. In addition, we observed several gaps approximately ½ inch wide around the perimeter of the roll-up door, a live spider in the blending room and two dead insects in the tablet room. In addition, your firm does not have written procedures for the maintenance, cleaning and sanitation of the facility. We acknowledge your response, dated July 7, 2017; however, we find your response to be inadequate in that you only provided photos of rodent traps and failed to provide actual written procedures for cleaning and pest control. 8. You failed to maintain roads, yards and parking lots so that they do not constitute a source of contamination in areas where components, dietary supplements or contact surfaces are exposed, as required by 21 CFR (a)(2). Specifically, you store components and finished products in tents outside in the yard. There is overgrown foliage from the neighboring yard behind the tents, creating a harborage area which can attract pests. adequacy of your response because you failed to address how you plan to maintain roads, yards, and parking lots so that they do not constitute a source of contamination for your dietary supplement products. 9. You failed to establish specifications for the labeling of the finished packaged and labeled dietary supplements, including specifications that ensure that you applied the specified label, as required by 21 CFR (g). In addition, you failed to establish specifications that provide sufficient assurance that the product that you receive from a supplier for packaging or labeling as a dietary supplement (and for distribution rather than for return to the supplier) is adequately identified and is consistent with your purchase order, as required by 21 CFR (f). Specifically, you did not establish such specifications for your EssenceLife Bee Propolis product for which you conduct labeling operations. 10. You failed to establish and follow written procedures for fulfilling the requirements for equipment, utensils, including calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement, as required under 21 CFR (a). For example, you failed to calibrate instruments or controls used in packaging of your dietary supplement, as

5 required by 21 CFR (b). Furthermore, you did not make and keep records of calibrating instruments and controls that you use in manufacturing or testing a component or dietary supplement as required by 21 CFR (b)(3). Specifically, during the inspection our investigators found that your firm did not have documentation relating to the calibration of two scales used for measuring ingredients and checking tablet and capsule weights. adequacy of your response. Although you provided an SOP for calibrating scales and instruments, you did not provide any calibration records to demonstrate implementation of the SOP. Misbranding 1. Your EssenceLife Bee Propolis, Youth Life L-Carnitine, and Youth Life Calcium products are misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. 343 (i)(2)] in that the product labels fail to declare the common or usual names of each ingredient used as required by 21 CFR For example: a. Your EssenceLife Bee Propolis product is manufactured using propylene glycol, according to the Certificate of Analysis (COA); however, you fail to declare this ingredient on your finished product label. b. Your Youth Life Calcium product is manufactured into capsules; however, you fail to include the capsule ingredients on your finished product label. c. Your Youth Life L-Carnitine product is manufactured using silicon dioxide, magnesium stearate, white rice powder, and gelatin, according to the COA; however, you fail to declare these ingredients on your finished product bulk label. 2. Your EssenceLife Bee Propolis and Youth Life Collagen products are misbranded within the meaning of 403(s)(2)(B) of the Act [21 U.S.C. 343 (s)(2)(b)] because the EssenceLife Bee Propolis product label fails to identify the product by using the term dietary supplement as a part of the product s statement of identity and the Youth Life Collagen product label fails to place the identification as a dietary supplement on the principal display panel, as required by 21 CFR (g) and 21 CFR Your EssenceLife Bee Propolis product is misbranded within the meaning of section 403(q)(1) (A) of the Act [21 U.S.C. 343 (q)(1)(a)] because the serving size declared on the label is incorrect. Serving size for a dietary supplement is the maximum amount consumed per eating occasion as recommended on the product label as defined in 21 CFR 101.9(b) and 21 CFR (b) Table 2. The suggested use states the consumer take 2-5 drops once, but the serving size lists 1 oz./30 ml. The serving size listed should be 5 drops. 4. Your Youth Life Collagen, EssenceLife Bee Propolis, and Youth Life Calcium product labels 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 presentation of the nutrition information on the labeling does not comply with 21 CFR For example: a. Your Youth Life Collagen and Youth Life Calcium product labels fail to present the nutrition information in the correct format and layout in accordance with 21 CFR (e).

6 b. Your Youth Life Calcium product label fails to declare the source of calcium. The source of each dietary ingredient must be designated on the label in accordance with 21 CFR (d). c. Your Youth Life Collagen product label bears an asterisk in the column under the heading %DV, but fails to refer to an asterisk placed at the bottom of the nutrition label and followed by the statement Daily Value not established, as required by 21 CFR (b)(2)(iii)(F). d. Your EssenceLife Bee Propolis product label fails to bear the column heading Amount Per Serving or present the quantitative amount of the dietary ingredient under that heading, in accordance with 21 CFR (b)(3)(ii) and (b)(2)(i)(A). Furthermore, the quantitative amount of EssenceLife Bee Propolis per serving should reasonably correlate with the serving size as related to the suggested use. 5. Your Youth Life Collagen product label is misbranded within the meaning of Section 403(q)(1) (B) of the Act [21 U.S.C. 343(q)(1)(B)] because the label fails to declare the servings per container in accordance with 21 CFR (b)(1)(ii). The above violations are not intended to be an all-inclusive statement of violations that exist in your facility or in connection with your products. It is your responsibility to ensure that your firm complies with all applicable requirements of federal law, the Act, and it s implementing regulations. You should take prompt action to correct violations cited in this letter and establish procedures to ensure such violations do not recur. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure or injunction. In addition to the violations noted above, we offer you the following comments: Your Youth Life Collagen, Youth Life Calcium, and EssenceLife Bee Propolis product labels bear the Supplement Facts on the panel located to the left of the principal display panel. This information belongs in the information panel located to the right of the principal display panel. Your Youth Life Collagen product label refers to Inactive Ingredient. The correct term is ingredients or other ingredients per 21 CFR 101.4(g). Your Youth Life Calcium product bears the statement *Daily Value (%DV) no established but does not declare any other dietary ingredients for which the statement *Daily Value not established would be required. 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 re-inspection-related costs. A re-inspection 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. Re-inspection-related costs means all expenses, including administrative expenses, incurred in connection with FDA s arranging, conducting, and evaluating the results of the re-inspection and assessing and collecting the re-inspection fees [21 U.S.C. 379j-31(a)(2)(B)]. For a domestic facility, FDA will assess and collect fees for re-inspection-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 re-inspection-related to costs from the responsible party for the domestic facility. The inspection noted in this letter identified noncompliance materially related to a food

7 safety requirement of the Act. Accordingly, FDA may assess fees to cover any re-inspection related costs. Within fifteen (15) business days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the violations noted above and to prevent these violations or other similar violations from occurring again. In your response, you should include documentation, including photographs, corrective actions you have taken to date, or other useful information 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 time within which you will complete the correction. If you have questions regarding this letter, please contact Tammy Hancock at Please reference Case# Sincerely Yours, /S/ Darla R. Bracy, District Director Office of Human and Animal Food Division 5 West More in 2017 (/ICECI/EnforcementActions/WarningLetters/2017/default.htm)