From March 2, 2017, through March 20, 2017, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility located at 410 W. 1st Avenue, Roselle, New Jersey. Our inspection revealed significant violations of Title 21 of the Code of Federal Regulations, Part 111 (21 CFR Part 111), Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. These violations cause your dietary supplement products to be adulterated within the meaning of Section 402(g)(l) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. ยง 342(g)(l)] in that they have been prepared, packed, or held under conditions that do not meet the CGMP regulations for dietary supplements found under 21 CFR Part 111. You may find the Act and the Code of Federal Regulations (CFR) through links on FDA's home page at
www.fda.gov.
The inspection revealed the following serious violations of the CGMP requirements for dietary supplements:
1. Your firm failed to establish product specifications for each dietary supplement that you manufacture 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 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 111.70(e). During the inspection, you stated that the finished product specifications for dietary supplement products that you manufacture are listed on the applicable certificates of analysis (C of A) for your products. However, the C of A for your Testosterone Wellness for Men product failed to include these required product specifications.
FDA received your written response, dated April 2nd, 2017; however, we are unable to evaluate the adequacy of your corrective action, as your response does not address the lack of adequate specifications. We note that once you have established finished product specifications, you must determine whether the specifications have been met, as required by 21CFR111.75(c). Relating to this requirement, we note that the C of A you provided do not list the actual test method you plan to use to determine if the product actually contains the dietary ingredients listed on your product labels; rather, your C of A identify all test methods "by input." Relying solely on the amount input is not a valid scientific method of confirming that specifications for identity, purity, strength, and composition of the finished batch are met. We also note that testing for potency of at least three of the dietary ingredients, as provided in your revised SOP, does not address the requirements for verifying identity, purity, or composition of the finished dietary supplement.
2. Your firm failed to conduct at least one appropriate test or examination to verify the identity of a component that is dietary ingredient, prior to its use, as required by 21 CFR 111.75(a)(l)(i). Specifically, you stated during the inspection that you rely on Fourier transform infrared spectroscopy (FTIR) for identity testing for dietary ingredients. While FTIR may be used to confirm that the supplier is consistent in sending the same product, FTIR does not ensure that the product received is what it is claimed to be. To verify the identity of a component that is a dietary ingredient, you must first authenticate that the ingredient is what it is stated to be, and then you may use that FTIR as a secondary authentication spectrum.
FDA received your written response, dated April 2nd, 2017; however, we are unable to evaluate the adequacy of your corrective action. Your revised SOP states that raw materials should be tested for identification by using FTIR; that in-house HPLC analysis should be performed for one out of three batches if the supplier is the same, and that if the product fails in testing, then three consecutive batches should be tested; and that both FTIR and in-house HPLC testing will involve a chemist comparing all analytical graphs of the sample with the analytical graphs of previously established standards. It is unclear which previously established standards you are referring to or how such testing will verify the identity of each component that is a dietary ingredient.
3. Your furn failed to establish component specifications that are necessary to ensure that specifications for purity, strength and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2). Specifically, your furn does not have component specifications for certain dietary supplements you manufacture. During the inspection, when asked what specifications are used to compare against the C of A's, you stated that you compare the color, odor, and texture of the components against what is listed on the C of A, and that if these characteristics match, you then perform the FTIR analysis. While, as previously noted, such steps may confrrm that the product appears to match the C of A and previous shipments, these specifications are insufficient to ensure the purity, strength, and composition of the component. Once you have established the required component specifications, you must also confirm the identity of components that are not dietary ingredients and determine whether applicable component specifications established in accordance with 21 CFR 111.70(b) are met by complying with one of the following:
a. Conducting appropriate tests or examinations, or
b. Relying on a C of A from the supplier of the component that you receive, provided that:
i. You first qualify the supplier by establishing the reliability of the C of A through confirmation of the results of the supplier's tests or examinations;
ii. The C of A includes a description of the test of examination method(s) used, limits of the test or examinations, and actual results of the tests or examinations;
iii. You maintain documentation of how you qualified the supplier;
iv. You periodically re-confirm the supplier's certificate of analysis; and
v. Your quality control personnel review and approve the documentation setting forth the basis for qualification (and re-qualification) of any supplier.
FDA received your written response, dated April 2nd, 2017; however, we are unable to evaluate the adequacy of your corrective action. Your response states, "All incoming raw materials are verified against the established standards and this verification is done for organoleptic properties. FTIR for identity and a HPLC testing is performed for the purity testing based on our SOP for testing for raw materials." However, it is unclear what "established standards" you are referring to or how this response addresses the insufficiency of your component specifications noted during the inspection. We also note that, while your response asserts that you have established processes used to confirm certain component specifications, such as those for Niacinamide Granular, the documentation you provided fails to demonstrate that you performed the process according to the associated Raw Material Release Certificate and what appears to be the laboratory notes for the testing conducted.
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. 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 all of your firm's products are in compliance 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 by FDA without further notice, such as seizure or injunction.
You should notify this office in writing within fifteen working days of receipt of this letter of the specific steps that you have taken to correct violations, including an explanation of each step taken to prevent the recurrence of violations and copies of supporting documentation. 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.
