FDA WARNING_LETTER - George Packing Company, Inc. - March 24, 2011

An FDA inspection of George Packing Company, Inc.'s hazelnut packing house and warehouse in Newberg, Oregon, conducted from March 1-24, 2011, revealed significant violations. The firm's hazelnuts were found to be adulterated under section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. § 342(a)(4)] due to insanitary conditions. Investigators observed a dead rodent, gnawed hazelnuts, numerous rodent pellets, and gaps in rolling doors large enough for rodent access. Although the door gaps were corrected during the inspection, evidence indicated rodents had already entered the facility. Additionally, the hazelnuts were adulterated under section 402(a)(3) of the Act [21 U.S.C. § 342(a)(3)], as samples contained filthy, putrid, or decomposed substances, including mouse pellets, gnaw marks, feathers, human hair, mouse hair, and dog/cat hair. While the firm responded to the FDA 483, stating staff cleaned and sanitized the facility, they failed to provide specific documentation of the procedures, hindering FDA's evaluation. The FDA requires a written response within fifteen days detailing corrective actions, completion timelines, and supporting documentation to prevent recurrence. Failure to comply may lead to regulatory actions like seizure or injunction.