What happened
Original notice title
Quality Supplement Manufacturing, Inc. MARCS-CMS 637182, December 13, 2022
From the archived source record
Based on inspectional findings and a 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 that document and our comments are listed following each of the significant violations. Adulterated Dietary Supplements The inspection of your facility revealed serious violations of the 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 (CFR), Part 111 (21 CFR Part 111). Based on the inspection, we determined that your products, including your (b)(4) , and (b)(4) products are 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 requirements for dietary supplements. The significant violations documented during the inspection include, but are not limited to the following: 1. Misbranded Dietary Supplements In addition, even if your (b)(4) product was not an unapproved new and misbranded drug, this product and others would be misbranded under section 403 of the Act because it does not comply with the labeling requirements for dietary supplements. Your (b)(4) and (b)(4) dietary supplement products are misbranded under section 403(q)(5)(F) of the Act [21 U.S.C. § 343(q)(5)(F)] in that the presentation of nutrition information on the labeling for your products does not comply with the labeling requirements for dietary supplements in 21 CFR 101.36. Your (b)(4) product is misbranded within the meaning of section 403(w)(2) of the Act [21 U.S.C. § 343(w)(2)], in that the finished product labels fail to declare the major food allergen, shrimp and crab, as required by section 403(w)(1) of the Act.
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
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- 99a9aede0177
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.
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