What happened
Original notice title
Inmar Supply Chain Solutions, LLC MARCS-CMS 666158, January 30, 2024
From the archived source record
Based on the inspectional findings, we have identified serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) and applicable regulations. Under section 301(a) of the Act [21 U.S.C. § 331(a), the introduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated is a prohibited act. Further, it is a prohibited act under section 301(k) of the Act [21 U.S.C. § 331(k)] to do any act with respect to a food, drug, device, or cosmetic, if such act is done while the products are held for sale after shipment in interstate commerce and results in the products being adulterated. We acknowledge your firm initiated a voluntary recall of certain products regulated by the FDA that were stored and shipped to interstate customers from January 1, 2023 through July 19, 2023 due to the presence of rodents and rodent activity at your firm. We have reviewed your responses and we discuss your significant violations and your corrective actions below. Adulterated Human Foods The inspection of your facility revealed serious violations of FDA’s regulations for Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Foods under Title 21, Code of Federal Regulations, Part 117 (21 CFR Part 117). These violations cause your human food and dietary supplement products to be adulterated within the meaning of section 402(a)(3) of the Act [21 U.S.C. § 342(a)(3)] in that your products consist in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food, and within the meaning of section 402(a)(4) of the Act [21 U.S.C. § 342(a)(4)] in that they have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with filth, or whereby they may have been rendered injurious to health. 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
- 085ffc86ace6
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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