Inmar Supply Chain Solutions, LLC

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

You did not exclude pests from your facility to protect against contamination of food, as required by 21 CFR 117.35(c). Specifically, our investigators observed evidence of rodent activity, including live rodents, dead rodents in various states of decay, rodent excreta pellets (REP), gnaw marks in food and food packaging, and odors indicative of rodent infestation throughout the entire facility including areas where human food is routinely stored.

Passage 2

You did not maintain your plant in a clean and sanitary condition and in repair adequate to prevent food from becoming adulterated, as required by 21 CFR 117.35(a). Specifically, insanitary conditions were observed around your facility demonstrating that sanitation and housekeeping operations were inadequate. These insanitary conditions are providing food sources and pest harborage areas for rodents and other pests.

Passage 3

the building used in the holding of drug products was not maintained in a clean and sanitary condition as required by 21 CFR 211.56(a) and was infested by rodents, insects, and other vermin.

Passage 4

the drug products were prepared, packed, or held under insanitary conditions whereby they may have been contaminated with filth or rendered injurious to health.

Passage 5

Devices 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, in violation of 501(a)(2)(A) of the Food, Drug and Cosmetic Act. Specifically, the devices held at your facility were exposed to significant rodent infestation. Investigators documented signs of rodent gnawing, live rodents, and apparent rodent like urine and scratches on the pallet of adult diapers and tampons.