FDA 483 - Family Dollar Distribution Inc. - February 11, 2022

This FDA Form 483, issued to Family Dollar Distribution Inc. in West Memphis, AR, following an inspection from January 11 to February 11, 2022, details ten observations concerning human food, animal food, and drug products.

For human food, the facility failed to exclude pests, with extensive rodent evidence including live and dead rodents, excreta, gnawings, nesting, and odors throughout. The plant was not maintained in a clean and sanitary condition, evidenced by spilled foods, a compactor with large gaps and a strong odor, and numerous gaps in dock doors, dock plates, and building seals. Grounds around the plant were not kept clean, with debris, food trash, and wooden pallet pieces piled near the compactor and under dock doors.

For animal food, products were not held under conditions protecting against contamination, with bagged pet foods showing rodent activity like gnaw holes, excreta, nesting, and live/dead rodents. Effective measures were not taken to exclude pests, with specific examples of gnawed pet food bags and rodent excreta. The firm failed to implement timely corrective action to prevent distribution of potentially contaminated or rodent-damaged products.

For drug products, buildings were not maintained clean and free of infestation, despite documentation of over 2300 rodent captures from March to September 2021, and over 1250 rats captured in January 2022. Rodent activity, including