What happened
Original notice title
Cosmax NBT USA MARCS-CMS 615933, May 03, 2023
From the archived source record
Based on the inspectional findings and review of your product labels we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. We have reviewed those responses and our comments are listed following each of the significant violations. Adulterated Dietary Supplements The inspection of your facility revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice (CGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements under Title 21, Code of Federal Regulations, Part 111 (21 CFR 111). These violations cause your dietary supplement products to be adulterated within the meaning of 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 CGMP regulations for dietary supplements. 1. 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 contaminants 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). You failed to verify that your finished batch of (b)(4) Lot (b)(4) meets products specifications for limits for those types of contamination that may adulterate or that may lead to adulteration of the finished batch of dietary supplement specifically, pesticides as required by 21 CFR 111.75(c). Misbranded Dietary Supplements In addition, the products, (b)(4) , and (b)(4) products are misbranded dietary supplements within the meaning of section 403 of the Act [21 U.S.C. § 343] because they do not comply with the labeling requirements for dietary supplements as required by 21 CFR 101 as follows: 1.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- fb5e25a02ae8
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →