What happened
Original notice title
InnoMark, Inc. MARCS-CMS 657518, September 01, 2023
From the archived source record
Based on inspectional findings and review of the labels collected during the inspection, we identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. We address your response below, in relation to the applicable violation. Adulterated Dietary Supplements During the inspection, our investigators found significant violations of Title 21, Code of Federal Regulations (CFR), Part 111 (21 CFR Part 111), Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements. These violations cause the (b)(4) , and (b)(4) sticks dietary supplements manufactured at your facility 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 requirements for dietary supplements. Your significant violations of the cGMP requirements are as follows: 1. You failed to confirm that the components you use meet the limits you have established on the types of contamination that may adulterate or lead to adulteration of the finished batch of the dietary supplement, as required by 21 CFR 111.75(a)(2). Specifically, during the inspection, you stated to our investigator that, to determine that the components you use meet the limits you have established on the types of contamination that may adulterate or lead to adulteration of the finished batch of the dietary supplement, your firm relies on supplier COAs for raw materials, including dietary ingredients, because your firm does not conduct testing for limits on certain contaminants, such as heavy metals and pesticides for powdered components and microbial specifications for liquid components. Additionally, you rely on supplier COAs that do not include test results for the contamination limits you have established, as required by 21 CFR 111.75(a)(2)(ii)(B).
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
- 88e336b92e8f
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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