Inspections, Compliance, Enforcement, and Criminal Investigations

Transcription

1 Page 1 of 5 Home Inspections, Compliance, Enforcement, and Criminal Investigations Enforcement Actions Warning Letters Inspections, Compliance, Enforcement, and Criminal Investigations V-SAB Medical Labs, Inc. 4/26/13 Department of Health and Human Services VIA UNITED PARCEL SERVICE April 26, 2013 Public Health Service Food and Drug Administration 60 Eighth Street, NE Atlanta, GA Telephone: WARNING LETTER 13-ATL-15 Rashid A. Buttar, D.O. President and Chief Operating Officer V-SAB Medical Labs, Inc Torrence Chapel Rd. Suite #204 Dear Dr. Buttar: This letter is in reference to the inspection conducted of your firm, V-SAB Medical Labs, Inc., on May 22, 2012 through June 20, 2012 and your firm s manufacture, marketing, and distribution of the topically administered products: Trans-D Tropin, TD-DMPS, and Progesterone-3/.3. Your products are manufactured, marketed, and distributed in violation the Federal Food, Drug, and Cosmetic Act ( the Act ) as described herein. You promote the aforementioned products on your websites, which include and as well as in YouTube videos and during radio appearances. These websites and media demonstrate that your products are intended for the diagnosis, cure, mitigation, treatment, or prevention of disease, and/or are intended to affect the structure or function of the body of man. Therefore, your products are drugs as defined by section 201(g) of the Act, [21 U.S.C. 321(g)]. Examples of the claims for your products include, but are not limited to, the following: Trans-D Tropin The following statements are located in your Trans-D Tropin product brochure located on your website, through which you sell Trans-D Tropin: Trans-D Tropin is the world s first and only Transdermal Growth Hormone Releasing (GHRH) Analog.... Recent studies show statistically significant increases in hgh levels from baseline, after treatment with Trans-D Tropin. You are a candidate for Trans-D Tropin if you have: Chronic Pain (e.g. Arthritis)... Blood Sugar Abnormalities (hypoglycemia or hyperglycemia) [,] Elevated LDL Cholesterol

2 Page 2 of 5 [,] Reduced HDL Cholesterol... Emotional Instability and/or Depression... Reduced Sex Drive [,] Reduced Sexual Potency/Performance What are some of the Benefits of Trans-D Tropin? Doctors and Patients report... Faster healing and quicker recovery from acute injuries and after surgical procedures... Reduction in chronic pain from old injuries... Renewed interest in sex with enhanced performance and ability... Decrease in anxiety, stress and depression... Decrease in occurrence of general illness due to strengthened immune system TD-DMPS The following statement is located on your TD-DMPS product container label: Indications: May be used by your physician for heavy metal detoxification. Progesterone-3/.3 The following statements are located in your Progesterone-3/.3 product container label and product brochure, respectively: Indications: For use in female hormonal imbalances. Progesterone 3/.3 is indicated in female patients that may be experiencing symptoms of estrogen dominance and/ or adrenal exhaustion. In addition, patients may benefit from the administration of Progesterone 3/.3 if they are seeking to increase bone mass density... prevent or reduce the symptoms of fibrocystic breast disease and uterine fibroids, reduce the symptoms of PMS, improve and maintain the uterine lining (as is beneficial in endometriosis... alleviate depression and anxiety... Furthermore, your various websites contain links to articles and videos about the purported utility of your products. When such references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product s intended uses. A citation of a publication or reference in the labeling of a product is considered to be a claim about the disease treatment or prevention if the citation refers to a disease use, and if the citation implies treatment or prevention of a disease in the context of the labeling as a whole. The following are examples of articles or papers used on your websites to market your products: Buttar, Rashid A. The Inter-relationship between Growth Hormone, IGF 1, and Cancer. Available from 1. Buttar, Rashid A. Position Statement regarding Dr. Buttar s TD-DMPS Treatment Protocol. Available from 2. Bernhoft, Robin and Buttar, Rashid. Autism: A Multi-System Oxidative and Inflammatory Disorder. Townsend Letter April; Available from 3. The intended uses of your products, Trans-D Tropin, TD-DMPS, and Progesterone-3/.3, make clear that they are drugs as defined in section 201(g)(1) of the Act [21 U.S.C. 321(g) (1)]. Moreover, these products are new drugs as defined in section 201(p) of the Act [21 U.S.C. 321(p)] because your drugs are not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in their labeling. Under section 505(a) of the Act [21 U.S.C. 355(a)], a new drug may not be introduced or delivered for introduction into interstate commerce unless an approved application is in effect for it. 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. The introduction of a drug into interstate commerce that is in violation of 505 is a violation of section 301(d) of the Act [21 U.S.C. 331(d)]. Your products, Trans-D Tropin, TD-DMPS, and Progesterone-3/.3, are also 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

3 Page 3 of 5 bear adequate directions for use. Trans-D Tropin, TD DMPS, and Progesterone.3/3 are considered prescription drugs under section 503(b)(1) of the Act [21 U.S.C. 353(b)(1)] and are not exempt under 21 C.F.R (c)(2) and from the requirement that their labeling bear adequate directions for use because these products lack approved applications. The introduction of a misbranded drug into interstate commerce is a violation of section 301(a) and/or 301(k) of the Act [21 U.S.C. 331(a) and/or 331(k)]. In addition, our investigator(s) identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, Title 21, Code of Federal Regulations, Parts 210 and 211. These violations cause your drug products to be adulterated within the meaning of section 501(a)(2)(B) of the Act [21 U.S.C. 351(a)(2)(B)] in that the methods used in, or the facilities or controls used for, their manufacture, processing, packing, or holding do not conform to, or are not operated or administered in conformity with, CGMP. Our investigator(s) observed specific violations during the inspection, including, but not limited to, the following: CGMP Violations 1. Your firm does not have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 C.F.R (a)). For example, no analytical testing is performed to assess conformance to specifications including the strength of each active pharmaceutical ingredient prior to releasing products for distribution. This is a repeat observation from the 2010 inspection. 2. Your firm failed to conduct at least one specific identity test to verify the identity of each component (21 C.F.R (d)(1)). For example, your firm did not conduct a specific identity test for the progesterone component lot (b)(4) used to manufacture Progesterone-3/.3, lot , on March 5, During the inspection, your lab director confirmed that your firm does not have the instrumentation needed to perform specific identity testing and indicated that (b)(4) was conducted for this component. However, you had no documentation of the (b)(4) test results for progesterone. In your response, provide your plans (e.g., using a contract laboratory) for performing this specific identification test on each incoming component lot, and provisions for addressing inadequate documentation of testing performed by your laboratory. 3. Your firm failed to establish an adequate written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 C.F.R (a)). For example, all of your products are labeled with a 1-year expiration date; however, there is no stability data to support this expiration dating. This is a repeat observation from the 2010 inspection. 4. Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 C.F.R (b)). For example, your test methods for the determination of total aerobic counts in topically applied products do not include instructions for preparation of media, provisions for the use of positive and negative controls, growth promotion testing, or instructions that require the use of suitable oxygen-permeable bags for incubating your plates.

4 Page 4 of 5 In addition, you have not established adequate specifications for objectionable microorganisms in your drug products based on the products intended use. For example, your topical products should be free of Staphylococcus aureus and Pseudomonas aeruginosa. However, your firm does not test for these organisms, and you have not performed an evaluation of your products to determine the organisms that are objectionable for these products. This is a repeat observation from the 2010 inspection. Repeat citations from prior inspections indicate that your quality control unit is not exercising its responsibilities, and may not have the appropriate authority to carry out its responsibilities. Due to continuing CGMP issues at your firm, if you intend to continue to manufacture drug products we recommend you engage a third party consultant with appropriate CGMP expertise to assess your firm s facility, procedures, processes, and systems to ensure that the drug products you manufacture have their appropriate identity, strength, quality, purity and safety. Your firm, V-SAB Medical Labs, distributes the before-mentioned unapproved new, misbranded, and adulterated drugs in interstate commerce to other physicians and healthcare providers in violation of sections 301(d) and 301(a) of the Act [21 U.S.C. 331(d) and (a)]. You also hold these drugs for use in your own medical practice, SA Buttar Health and Medical, PC (d.b.a. Center for Advanced Medicine and Research) in violation of section 301(k) of the Act [21 U.S.C. 331(k)]. The issues and violations cited in this letter are not intended to be an all-inclusive statement 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, with respect to the products specifically identified in this letter and also with respect to all other products that you manufacture. It is your responsibility to ensure that your firm complies with all requirements of federal law and FDA regulations. In this regard, please note that products are misbranded under section 502(j) of the Act [21 U.S.C. 352(j)] if they are dangerous to health when used in the dosage or manner; or with the frequency or duration prescribed, recommended, or suggested in the products labeling. You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in legal action, without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts. Please notify this office in writing within fifteen (15) working days from the date you receive this letter of the specific steps you have taken to correct the noted violations. Include an explanation of each step being taken to prevent recurrence of violations as well as any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which you will complete the corrections. Additionally, if another firm manufactures the product identified above, your reply should include the name and address of the manufacturer. If the firm from which you receive the product is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Your written response should be sent to Marie Mathews, Compliance Officer, U.S. Food and Drug Administration, 60 Eighth Street NE, Atlanta, Georgia If you have any questions about this letter please contact Ms. Mathews at (404) or by at marie.mathews@fda.hhs.gov. Sincerely, /S/ John R. Gridley, Director Atlanta District Cc Dean Viktora CEO,

5 Page 5 of 5 AMT/Balance Distribution Torrence Chapel Road Suite #204 Dean Viktora, CEO AMT/Balance Distribution 9815-J Sam Furr Road #230 Huntersville, NC Rashid Buttar, DO West Catawba Avenue Suite 100 Page Last Updated: 05/20/2013 Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players. Accessibility Contact FDA Careers FDA Basics FOIA No Fear Act Site Map Transparency Website Policies U.S. Food and Drug Administration New Hampshire Avenue Silver Spring, MD Ph INFO-FDA ( ) FDA For Government For Press Combination Products Advisory Committees Science & Research Regulatory Information Safety Emergency Preparedness International Programs News & Events Training and Continuing Education Inspections/Compliance State & Local Officials Consumers Industry Health Professionals FDA Archive Links on this page: