- Ajes Pharmaceuticals LLC
- Issuing Office:
- New York District Office
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
New York District
158-15 Liberty Avenue
Jamaica, New York 11433
September 9, 2016
WARNING LETTER NYK 2016-42
VIA UNITED PARCEL
SERVICE SIGNATURE REQUIRED
Ms. Asha Patel, Vice-President/Co-Owner
Ajes Pharmaceuticals, LLC
11 Lincoln Street
Copiague, NY 11726-1530
Dear Ms. Patel:
The U.S. Food and Drug Administration (FDA) conducted an inspection of your dietary supplement facility, located at 11 Lincoln Street, Copiague, NY, from February 23 through March 9, 2016. We found serious violations of the current Good Manufacturing Practice (cGMP) regulations for Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements, Title 21, Code of Federal Regulations (CFR), 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 the dietary supplements have been prepared, packed, or held under conditions that do not meet cGMP requirements for dietary supplements. Our investigators' observations were noted on form FDA-483, Inspectional Observations, which was issued to you on March 9, 2016. We received a written response from you dated March 28, 2016, concerning our investigators' observations noted on the FDA-483 issued to you. We address each relevant response, in relation to each of the noted violations.
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Our inspection revealed the following violations of the dietary supplement cGMP regulation:
1. You failed to establish product specifications for the identity, purity, strength, and composition of your finished batches of the 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 to ensure the quality of the dietary supplements, as required by 21 CFR 111.70(e). Specifically, your firm's certificate of analyses (COA) for finished product assay testing for (b)(4) Capsule and (b)(4) Capsule indicates assay testing was based on input, suchas your personnel adding the ingredients to the batch of product, at the time of manufacturing, and was not based on performing analytical testing of the finished product. You have not established specifications for identity, purity, strength, and composition of the finished batch of dietary supplement, as required by 21 CFR 111.70(e).
Once you have established product specifications for the finished batch of dietary supplement, you must verify that the specifications are met in accordance with 21 CFR 111.75(c).
We have reviewed your written response dated March 28, 2016. Your response stated that you had taken measures to ensure finished product testing and to ensure specifications were met for identity, purity, strength and composition. You provided documentation of the chromatogram for a newer lot of (b)(4) capsules, lot #(b)(4) and testing results for the Zinc mineral in (b)(4) capsules (Lot #(b)(4)). You did not provide complete finished product specifications and their acceptance criteria for the above products, which are mutli-dietary ingredient products. We intend to verify that adequacy of your corrective action at a future inspection.
2. You failed to establish any of the following specifications for the (b)(4) Capsule, Lot #(b)(4) product you manufacture, such as identity specifications for each component that you use in the manufacture of a dietary supplement, as required by 21 CFR 111.70(b)(1); and component specifications for each component that you use in the manufacture of a dietary supplement that are necessary to ensure that specifications of the purity, strength and composition of dietary supplements manufactured using the components are met, as required by 21 CFR 111.70(b)(2).
Once you have established the specifications for each component, you must verify that the specifications are met in accordance with 21 CFR 111.75(a), and you must make and keep records in accordance with 21 CFR 111.95(b).
We have reviewed your written response dated March 28, 2016. Your response includes certificates of analysis (COA) for the raw materials that you used in the manufacture of your dietary supplements. For example, you provided COAs for the raw materials used in the manufacture of (b)(4) Capsule product, Eurycoma Longifolia 100:1 powder and LJ100 powder. However, your response is inadequate in that the COAs do not contain sufficient information to determine if the product meets its specifications (e.g., there are no reference materials identified, no methods identified, and no acceptance criteria identified). Further, although you provided a previous chromatogram for Eurycoma Longifolia, you did not establish an identity specification for this dietary ingredient and your COA provides insufficient information to determme the identity of this dietary ingredient.
3. Your firm did not collect and hold reserve samples of each lot of packaged and labeled dietary supplements that you distribute, as required by 21 CFR 111.83(a). For each lot of packaged and labeled dietary supplements that you distribute, your firm must collect reserve samples and hold the samples in accordance with 21 CFR 111.83(b). For example:
• Be held using the same container-closure system in which the packaged and labeled dietary supplements were distributed [21 CFR 111.83(b)(1)];
• Be identified with the appropriate batch, lot, or control number [21 CFR 111.83(b)(2)];
• Be retained for at least ( l) year past the shelf life date (if shelf life dating is used), or for two (2) years from the date of distribution of the last batch of dietary supplements associated with the reserve sample [21 CFR 111.83(b)(3)]; and
• Consist of at least twice the quantity necessary for all tests or examinations to determine whether or not the dietary supplement meets product specification [21 CFR 111.83(b)(4)].
We have reviewed your written response dated March 28, 2016. Your response stated you have taken measures to keep the "MANUFACTURED RETAIN FINISHED PRODUCT SAMPLES ONE YEARS PASSED THE SHELF LIFE...". However, you do not indicate whether you are holding these samples in compliance with all of the requirements under 21 CFR 111.83(b). We intend to verify that adequacy of your corrective action at a future inspection.
This letter is not an all-inclusive list of violations at your facility or deficiencies in your productsor their labeling. You are responsible for ensuring that your products are in compliance with the requirements of the Act and its implementing regulations.
Failure to promptly correct these violations may result in enforcement action without further notice, such as seizure and/or injunction.
Please respond in writing within fifteen (15) working days from your receipt of this letter. Your response should outline the specific things you are doing to further correct these violations. You should include in your response documentation 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.
Section 743 of the Act [21 U.S.C. 379j-31] authorizes FDA to assess and collect fees to cover the 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, the FDA may assess fees to cover any reinspection related costs.
Please send your written reply to Patricia A. Clark, Compliance Officer, U.S. Food and Drug Administration, 622 Main Street, Suite100, Buffalo, NY 14202. If you have any questions about this letter, you may contact Compliance Officer Patricia A. Clark at (716) 846-6236.
Matthew R. Palo
Lieutenant Commander, U.S. Public Health Service
District Director (acting)
New York District