Advanced Nutritional Technology Inc. warned by FDA for mislabeling products

Advanced Nutritional Technology Inc

The U.S. Food and Drug Administration (FDA) conducted an inspection of Advanced Nutritional Technology’s (“ANT”) dietary supplement facility and found “serious violations” of the Current Good Manufacturing Practice (CGMP) regulations for dietary supplements, Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111). These violations cause ANT 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 products have been prepared, packed, or held under conditions that do not meet CGMP requirements for dietary supplements.
In addition, the FDA reviewed the labeling of ANT products and its website at www.advancednutritionaltech.com. Based on this review, the FDA concluded that certain ANT products are in violation of sections 403, 505(a), and/or 502(f)(1) of the Act [21 U.S.C. §§ 343, 355(a), and/or 352(f)(1)] and the regulations implementing the food labeling requirements of the Act, which are found in Title 21, Code of Federal Regulations, Part 101 (21 CFR 101).
The FDA Warning Letter stated in part:
Dietary Supplement CGMP Violations
1)    You failed to package and label in a way that ensures that the dietary supplement is packaged and labeled as specified in the MMR, as required by 21 CFR 111.415. Specifically, during the inspection, the FDA investigator observed 308 bottles of Super EPA 2000, Control No. 120109, Expiration Date: 01/2015, which your firm had packaged and labeled. You were unable to provide a master manufacturing record for the packaging and labeling of this product. A master manufacturing record for a firm that only packages and labels the dietary supplement must include specifications that are applicable to its operations. [See 72 Fed. Reg. 34752, 34902 (June 25, 2007)].
You stated during the inspection that your firm would cease packaging and labeling retail-sized products. However, FDA is aware that retail purchases can still be made of the repackaged product.
2)    You did not 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, you stated that your firm does not have or follow written procedures for quality control operations. In addition, you could not provide records or documentation showing that your firm performs any quality control operations.
3)    You did not prepare a batch production record every time you manufactured a batch of dietary supplements, as required by 21 CFR 111.255 and 111.260. Specifically, during the inspection, the FDA investigator observed 308 bottles of Super EPA 2000, Control No. 120109, Expiration Date: 01/2015, which your firm had packaged and labeled. You were unable to provide a batch production record for this product, and you stated that such a record had not been made.
As is discussed above, you stated that your firm would cease packaging and labeling retail-sized products; however, it appears that you have not ceased such operations.
4)    You did not establish and follow written procedures for fulfilling the requirements relating to the packaging and labels you receive, as required by 21 CFR 111.153, nor did you make and keep the records required by 21 CFR 111.180(b). Specifically, you stated that you did not have any written procedures to meet the requirements (set forth in 21 CFR 111.160) that apply to the packaging and labels you received and used in the packaging and labeling of your Super EPA 2000 product. Furthermore, you were unable to produce records showing that those requirements had been met. Although you stated that you visually check the shipment against the purchase order to ensure consistency, you could not provide any records to verify this activity.
As is discussed above, you stated that your firm would cease packaging and labeling retail-sized products; however, it appears that you have not ceased such operations.
5)    You did not establish and follow written procedures for your dietary supplement holding and distributing operations, as required by 21 CFR 111.453, nor did you hold dietary supplements under conditions that do not lead to the mixup of the supplements, as required by 21 CFR 111.455(c). Specifically, during the inspection, the FDA investigator observed dietary supplement product held in paper cartons that were hand-marked with the letter “A”; when asked to identify the product, your office manager, who was in charge of the operation that day in your absence, stated that she was uncertain, and that the letter “A” probably stands for Vitamin A. In addition, you had no written procedures for holding and distribution of your products and stated that you did not make or keep written procedures for this operation.
We note that you stated at the conclusion of the inspection that you would develop procedures for holding and distributing operations within three months. We will verify this correction at our next inspection.
6)    You did not establish and follow written procedures to fulfill the requirements (set forth in 21 CFR 111.560) that apply to the review and investigation of product complaints, as required by 21 CFR 111.553. Specifically, you stated that you do not have written complaint handling procedures.
We note that you stated at the conclusion of the inspection that you would develop complaint handling procedures within three months. We will verify this correction at our next inspection.
7)    You did not establish and follow written procedures to fulfill the requirements (set forth in 21 CFR subpart N) for the handling of returned dietary supplements, as required by 21 CFR 111.503. Specifically, you stated that you do not have written procedures for handling returned products.
We note that you stated at the conclusion of the inspection that you would develop procedures to handle returned dietary supplements within three months. We will verify this correction at our next inspection.
8)    You have not established and followed written procedures for fulfilling the requirements relating to the prevention of microbial contamination (as set forth in 21 CFR 111.10(a)) or for fulfilling the requirements relating to hygienic practices (as set forth in 21 CFR 111.10(b)), as required by 21 CFR 111.8. Specifically, the FDA investigator observed an employee packaging and labeling Super EPA 2000 product, which involved hand-manipulation of exposed product; however, you do not have procedures in place to fulfill the requirements relating to preventing microbial contamination from sick or infected personnel or relating to hygienic practices.
As is discussed above, you stated that your firm would cease packaging and labeling retail-sized products; however, it appears that you have not ceased such operations.
Misbranding of Dietary Supplements:
Your Co Enzyme Q10 product is misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 343(s)(2)(B)] in that the label fails to identify the product using the term ‘dietary supplement,’ or other appropriately descriptive term, in accordance with 21 CFR 101.3(g).
Your Co Enzyme Q10 product is also misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the label fails to bear nutrition information in the form of a Supplement Facts panel in accordance with 21 CFR 101.36.
Your Co Enzyme Q10 product is also misbranded within the meaning of section 403(y) of the Act [21 U.S.C. § 343(y)] in that it fails to include a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event related to your product.

Submit a Response Are you having the same issue? Do you have a solution? Either way, chime in!

I would like to speak with a lawyer about my legal rights in this matter.

I have read and agree to the Terms and Conditions.

Contact A Lawyer Privately

  • This field is for validation purposes and should be left unchanged.