Source: https://www.fda.gov/ICECI/EnforcementActions/WarningLetters/2016/ucm498992.htm
Timestamp: 2019-04-21 06:49:40+00:00

Document:
The U.S. Food and Drug Administration (FDA) inspected your facility in Ronkonkoma, New York, from December 22, 2015, through January 5, 2016. Our investigation identified serious violations of FDA’s Current Good Manufacturing Practice (CGMP) regulation for dietary supplements, Title 21, Code of Federal Regulations, Part 111 (21 CFR Part 111). These violations cause your dietary supplement products to be adulterated under Section 402(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 342(g)(1)] because they have been prepared, packed or held under conditions that do not meet the CGMP regulation for dietary supplements. In addition, FDA reviewed your product labels. Based on our review, we have concluded that your products identified below are misbranded within the meaning of section 403 of the FD&C Act [21 U.S.C. § 343]. You may find the Act and its implementing regulations through links on the FDA’s home page at www.fda.gov.
You failed to establish product specifications 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 that 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). Specifically, your firm has not established product specifications for your Prenatal Formula Tablets, Neuroxygen Capsules, Formula for Men Capsules, and Mulberry Leaf Capsules.
Once you have established the required product specifications, you must verify that the specifications are met in accordance with 21 CFR 111.75(c), and you must make and keep records for established specifications, as required by 21 CFR 111.95(b)(1).
2. Your firm failed to conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required under 21 CFR 111.75(a)(1)(i), and you have not petitioned FDA for an exemption from this requirement under 21 CFR 111.75(a)(1)(ii). Specifically, you did not perform dietary ingredient identity testing, nor have you petitioned for an exemption from such testing, for any dietary ingredient that your firm used to manufacture your Prenatal Formula Tablets, Neuroxygen Capsules, Formula For Men Capsules, and Mulberry Leaf Capsules.
We note that for each component that you use in the manufacture of a dietary supplement, you must establish specifications for identity, purity, strength, composition, and limits on contaminants, as required by 21 CFR 111.70(b). As noted above, for components that are dietary ingredients, you must conduct at least one appropriate test or examination to verify the identity of any component that is a dietary ingredient, as required by 21 CFR 111.75(a)(1)(i), unless you petition for an exemption under 21 CFR 111.75(a)(1)(ii). For components that are not dietary ingredients, you must confirm the identity of such components and determine whether other applicable component specifications established in accordance with 21 CFR 111.70(b) are met, as required by 21 CFR 111.75(a)(2). Further, you must make and keep records of the specifications established, as required by 21 CFR 111.95(b)(1).
3. Your firm 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, as required by 21 CFR 111.103. Specifically, you have not established written procedures for quality control operations that include actions for conducting a material review, making a disposition decision, and approving or rejecting any reprocessing.
Once you have established your written quality control procedures you must implement quality control operations in your manufacturing, packaging, labeling, and holding operations for producing the dietary supplement to ensure the quality of the dietary supplement, as required by 21 CFR 111.65.
Procedures for sampling and a cross-reference to procedures for tests or examinations [21 CFR 111.210(h)(2)];Corrective action plans for use when a specification is not met [21 CFR 111.210(h)(5)].
c. The results of any testing or examination performed during the batch production, or a cross-reference to such results, as required by 21 CFR 111.260(h).
6. Your firm failed to establish and follow written procedures to fulfill the requirements related to product complaints, as required by 21 CFR 111.553, and for the review and investigation of product complaints, as required by 21 CFR 111.560. Specifically, your firm has no written procedures for reviewing and investigating product complaints.
1. Your “Neuroxygen Capsules” product is misbranded within the meaning of Section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that it fails to list the place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
2. Your “Neuroxygen Capsules” product is misbranded within the meaning of section 403(i)(2) of the Act [21 U.S.C. § 343 (i)(2)] in that it is fabricated from two or more ingredients, and each ingredient is not declared on the label by the common or usual name, in accordance with 21 CFR 101.4. Specifically, you fail to declare any ingredients on your product label.
The violations cited in this letter are not intended to be an all-inclusive list of violations at your facility or that exist in connection with your products or their labeling. 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 your firm complies with the Act and applicable FDA regulations. You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
Please respond to this letter in writing within 15 working days from your receipt of this letter. Your response should outline the specific steps you have taken to correct the violations listed above, including an explanation of how you plan to prevent these violations, or similar violations, from occurring again. You should include in your response documentation of the corrective actions you have taken. 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 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)]. 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 non-compliance materially related to a food safety requirement of the Act. Accordingly, FDA may assess fees to cover any costs related to re-inspection.
Your written response should be sent to LCDR Catherine M. Beer, Compliance Officer, U.S. Food and Drug Administration, One Winners Circle, Suite 110, Albany, New York 12205. If you have any questions about this letter, please contact Compliance Officer LCDR Catherine M. Beer at (518) 453-2314 x1015 or email at Catherine.beer@fda.hhs.gov.

References: § 342
 § 343
 § 343
 § 343
 § 379
 § 379