Inmar Supply Chain Solutions, LLC – FDA Warning Letter, Jul 19, 2023

The FDA inspected Inmar Supply Chain Solutions, LLC, from June 22, 2023, to July 19, 2023, identifying serious violations of the Federal Food, Drug, and Cosmetic Act. The facility holds and distributes human foods, cosmetics, OTC drugs, and devices. A voluntary recall was initiated due to rodent activity.

Violations include adulterated human foods and dietary supplements due to failure to exclude pests (21 CFR 117.35(c)) and maintain a clean facility (21 CFR 117.35(a)). Evidence included live and dead rodents, rodent excreta pellets (REP), gnaw marks on food and packaging, and foul odors. Pest control records from February 2022 to June 2023 documented 60 mice and 153 rats captured. Insanitary conditions like spilled food, open food wrappers, and holes in drywall were observed.

OTC drug products were adulterated (21 U.S.C. 351(a)(2)(B) and 351(a)(2)(A)) as the facility was not clean and sanitary, infested with rodents, and products were held under insanitary conditions. The firm was aware of the infestation since at least May 2022 but continued shipping products until July 14, 2023.

Devices were also adulterated (