CLOSEOUT LETTER
Bio TE Medical MARCS-CMS 520217 —
- Recipient:
- Bio TE Medical
United States
- Issuing Office:
- Dallas District Office
United States
| |
Division of Human and Animal Food Operations III West 4040 N. Central Expressway, Suite 300 Dallas, Texas 75204 |
May 22, 2017
2017-DAL-WL-19
WARNING LETTER
UPS Overnight
Dr. Gary S. Donovitz, Principal-Owner & Chairman
BioTE Medical, LLC
1875 W. Walnut Hill Lane, Suite 100
Irving, Texas 75038
Dear Dr. Donovitz:
From October 24, 2016 through November 4, 2016, the U.S. Food and Drug Administration (FDA) inspected your warehouse and distribution center located at 1875 Walnut Hill Lane, Suite 100, Irving, Texas where your dietary supplement products are received, stored, and distributed under the name, BioTE Medical. The inspection revealed serious violations of the FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements regulation, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products 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 insanitary conditions that do not meet CGMP regulation for dietary supplements. The inspectional observations were provided to Mr. Mark Hincher, President, on the Form FDA 483 Inspectional Observations issued, at the conclusion of our inspection.
In addition, FDA reviewed the labeling for BioTE DIM, BioTE Probiotic, BioTE Iodine Plus and BioTE Omega 3, including brochures and other promotional materials. The claims in your product labeling establish that the products are drugs under section 201(g)(1)(B)of the Act [21 U.S.C. § 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Furthermore, the labeling for BioTE DIM causes it to be misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] as detailed below. You can find the Act and FDA regulations through links on FDA’s website at www.fda.gov.
Unapproved New Drug Violations
Examples of some of the claims on your product labeling that provide evidence that your products are intended for use as drugs include:
BioTE DIM
Within your “All about DIM” marketing brochure
- “Therefore, DIM can help to further reduce the risk of atherosclerosis…help guard against prostate enlargement, a condition known as benign prostatic hypertrophy”
- “[E]ndometriosis…cervical dysplasia, have been observed to improve with DIM supplementation.”
BioTE Probiotic
Within your “AGE HEALTHIER AND LIVE HAPPIER bioTE Bio-Identical Hormone Balance for Men and Women” marketing brochure
- “Probiotics aide in the prevention of tooth decay and other oral health problems.”
BioTE Iodine Plus
Within your “AGE HEALTHIER AND LIVE HAPPIER bioTE Bio-Identical Hormone Balance for Men and Women” marketing brochure:
- “Adequate Iodine supplementation can control and reduce: ●ADD/ADHD ●Atherosclerosis ●Breast Diseases…●Fibrocystic Breast ●Goiter ●Ovarian Disease ●Parotid Duct Stone ●Peyronie’s ●Prostate Disorders…●Thyroid Disorders ●Vaginal Infections ●Hemorrhoids ●Headache/Migraines ●Hypertension ●Infections …●Liver Diseases”
BioTE Omega 3
Within your “AGE HEALTHIER AND LIVE HAPPIER bioTE Bio-Identical Hormone Balance for Men and Women” marketing brochure:
- “[B]lood clotting prevention…”
- “[A]rthritis relief…”
Your BioTE DIM, BioTE Probiotic, BioTE Iodine Plus, and BioTE Omega 3 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 and information demonstrating that the drug is safe and effective.
A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.500). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. § 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Your BioTE DIM and BioTE Iodine Plus products are intended for treatment of one or more diseases that are not amendable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, these products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. § 331(a)].
Adulterated Dietary Supplements
Even if your BioTE DIM, BiotTE Probiotic, BioTE Iodine Plus and BioTE Omega 3 products did not have therapeutic claims which make them unapproved new drugs, these products and all dietary supplement products that you distribute would still be adulterated under section 402(g)(1) of the Act [21 U.S.C. § 342(g)(1)] in that they have been prepared, packed, or held under conditions that do not meet the Current Good Manufacturing (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111).
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 111.103. Specifically, during the inspection it was observed that your firm had relabeled case packaging of dietary supplement products because the contract manufacturer had not properly labeled the cases. However, there was no evidence of quality control approving or rejecting any relabeling of the packaged and labeled dietary supplement, as required by 21 CFR 111.127(g), nor is there evidence of quality control approval for release, or rejecting of the relabeled dietary supplement for distribution, as required by 21 CFR 111.127(h). Additionally, you do not perform quality control functions, such as reviewing documentation from the manufacturers with whom you contract with relating to how your dietary supplement products are manufactured and whether they conform to established specifications.
Once you have established your written procedures for the responsibilities of quality control operations at your firm, you must implement quality control operations, as required by 21 CFR 111.65.
We have reviewed your firm’s response letter dated November 28, 2016. In your firm’s response, it states that your firm will immediately create, implement, and provide training for a system of quality control; however, we are unable to evaluate the adequacy of your response as you did not provide any quality control SOPs for review.
To the extent that a another firm manufactures dietary supplements on your behalf as a contract manufacturer 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. 34752, 34790 (Jun. 25, 2007)]. Although a firm may contract out certain dietary supplement manufacturing operations, it cannot 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 (1943) (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 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) and 331(a)). Thus, a firm that contracts out some or all of its operations must establish a system of production and process controls to ensure the quality of the dietary supplement and that the dietary supplement is packaged and labeled as specified in the master manufacturing record (21 CFR 111.55). 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 (21 CFR 111.105).
2. You failed to establish and follow written procedures to fulfill the requirements relating to product complaints, as required by 21 CFR 111.553. Specifically, during the inspection it was stated that your firm does not have SOPs related to complaint handling for dietary supplements. Once you establish the required written procedures relating to product complaints, you must make and keep written records of every product complaint that is related to current good manufacturing practices, in accordance with CFR 111.570(b)(2).
Within your firm’s response it states that while new formal processes are under development, your firm will stress the importance of thorough complaint documentation and analysis and will develop an interim manual method of compiling and reviewing this information; however, we are unable to evaluate the adequacy of your response as you did not provide a copy of an established written complaint procedure or documentation that such a procedure has been implemented.
3. You failed to establish and follow written procedures for holding and distributing operations, as required by 21 CFR 111.453. Specifically, your firm does not have written procedures for holding and distributing operations for the dietary supplement products your firm distributes.
Within your firm’s response it states that your firm will immediately create, implement, and provide training for a system of quality control SOPs appropriate for the private label distribution of dietary supplements; however, we are unable to evaluate the adequacy of your response as you did not provide any documentation of your written procedures for holding and distributing operations.
4. You failed to collect and hold reserve samples of each lot of packaged and labeled dietary supplement that you distribute, as required by 21 CFR 111.83(a). For each lot of packaged and labeled supplements that you distribute, your firm must collect reserve samples and hold the samples using the same container-closure system in which the packaged and labeled dietary supplements were distributed in accordance with 21 CFR 111.83(b)(1).
5. You failed to establish and follow written procedures for returned dietary supplements, as required by 21 CFR 111.503. Specifically, as of 10/24/2016, your firm received a return of 490 bottles of the dietary supplement, BioTE Iodine. The dietary supplement returned related to an improper seal; however, you did not identify and quarantine the returned supplements until a disposition decision was made by your quality control personnel in accordance with 21 CFR 111.510.
Within your firm’s response, it states that your firm is working on a procedure that will outline handling returned products; however, we are unable to evaluate the adequacy of your firm’s response as your firm did not provide a copy of the written procedure for returns.
Misbranded Dietary Supplement
Further, even if your BioTE DIM product was not an unapproved new drug, it would still be a misbranded dietary supplement 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 101.36. The label lists vitamin E as one of the BioTE DIM components. As a (b)(2)-dietary ingredient, vitamin E along with its quantitative amount by weight per serving and percent daily value must be declared in the (b)(2)-dietary ingredient section of the Supplement Facts in accordance with 21 CFR 101.36(c)(1).
(b)(3)(A)
(b)(3)(A)
As a responsible official of a facility that manufactures/processes, packs, or holds food for human or animal consumption in the United States, you are responsible for ensuring that your overall operation and the products you distribute are in compliance with the law. (b)(3)(A)
(b)(3)(A)
The above violations are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products. It is your responsibility to ensure that all the products you manufacture or distribute comply with the Act and its implementing regulations. 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, such as 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 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 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 all corrections before you respond, you should explain the reason for your delay and state when you will correct any remaining violations.
Your written response should be sent to Paul E. Frazier, Compliance Officer, U.S. Food and Drug Administration, 4040 North Central Expressway, Suite 300, Dallas, TX 75204. If you have questions regarding any issues in this letter, please contact Ms. Frazier at 214-253-5340.
Sincerely,
/S/
Shari J. Shambaugh
Acting District Director
Program Division Director
Office Human and Animal Food,
Division III West
Cc: Lori Woznicki, Food and Drug Inspections Branch Manager
Division of regulatory Services
Texas Department of State Health Services
1100 E. 49th Street – Mail Code 1987
Austin, Texas 78756
Cc: Mr. Mark Hincher, RPh, President
1875 W. Walnut Hill Lane, Suite 100
Irving, Texas 75038