FDA 483 - Nutripack LLC - February 08, 2017

This FDA Form 483 documents observations made during an inspection of a facility producing low-acid canned dog food. Two specific products were found to contain the barbiturate drug pentobarbital: "EVANGERS***HAND PACKED HUNK OF BEEF AUS JUS***NET WT 12 OZ****" coded 1816606HB13, and "AGAINST the Grain***GRAIN FREE PULLED BEEF with Gravy***DINNER FOR DOGS***NET WT 12 OZ****" coded 2415E01ATB12 BEST DEC 2019.

Further observations on January 10 and 11, 2017, noted significant sanitation issues. Condensate was observed dripping throughout the processing facility from the building framing, ceiling, walls, and from tarps suspended above food processing areas. This condensate dripped directly into open cans of the in-process "HUNK OF BEEF" low-acid canned dog food product, and also into multiple open totes of raw meats, including beef intended for the "HUNK OF BEEF" product. Additionally, the floors throughout the processing facility were found to be pitted, cracked, and otherwise damaged, leading to pooled water in areas where food was exposed, including where open cans of in-process "HUNK OF BEEF" dog food were staged on a wooden pallet directly on the damaged floor.