FDA 483 - Nutrispice LLC - January 31, 2017

An FDA inspection conducted at Nutripack LLC on January 10-12 and 31, 2017, identified several serious violations of the Federal Food, Drug, and Cosmetic Act. The most critical observation involved the adulteration of a low-acid canned dog food product, specifically "AGAINST the Grain***GRAIN FREE PULLED BEEF with Gravy," which chemical analysis confirmed contained the barbiturate drug pentobarbitol. Beyond product adulteration, the inspection revealed numerous insanitary conditions across the manufacturing and storage facility. Investigators observed condensate consistently dripping from the building frame and ceiling, including directly onto open cans of in-process dog food. There was also excessive pooling of condensation on stored product pallets and facility floors. Raw meats were prepared in direct contact with an insanitary, damaged concrete floor, and employees were seen cutting raw chicken on untreated wooden lumber. Furthermore, the storage facility exhibited active avian presence, with birds feeding on spilled pet food, resting in rafters, and flying within the warehouse. The facility's floors were noted to be pitted, cracked, and damaged, leading to standing water in areas where food was exposed. Nutripack LLC is required to address these critical observations by implementing comprehensive corrective actions to prevent further adulteration and ensure that all food products are prepared, packed, and held under sanitary conditions, thereby complying with federal food safety regulations.