FDA WARNING_LETTER - Homeneeds Samamish, Inc. - July 08, 2011

The FDA conducted an inspection of Homeneeds, Inc.'s food storage and repacking facility from June 20 to July 8, 2011, revealing serious violations of Current Good Manufacturing Practice (21 CFR Part 110). The inspection found food adulterated under Section 402(a)(4) of the Federal Food, Drug, and Cosmetic Act due to insanitary conditions, confirmed by laboratory tests showing rodent excreta, hair, urine, and gnawed packaging. Key violations included a pervasive failure to exclude pests and protect food from contamination (21 CFR 110.35(c)), evidenced by live and dead rodents, extensive rodent excreta pellets, urine stains, and gnaw holes on food packaging throughout the facility. The firm also failed to provide adequate pest screening (21 CFR 110.20(b)(7)), maintain plant construction for proper cleaning and repair (21 CFR 110.20(b)(4)), and properly dispose of rubbish to minimize pest attraction (21 CFR 110.37(f)). Additionally, finished food was improperly stored, leading to contamination risk (21 CFR 110.93), and litter/equipment attracting pests were not removed from the plant vicinity (21 CFR 110.20(a)(1)). Overall, the facility failed to maintain sanitary conditions (21 CFR 110.35(a)), with accumulations of dirt, refuse, and food spills. The firm's initial response to the FDA-483 was inadequate, lacking documentation of corrections and a plan to address the active rodent infestation. Homeneeds, Inc. must take prompt corrective action and respond in writing within 15 working days with detailed steps, supporting documentation, and a timeline to prevent recurrence, or face potential regulatory actions like seizure or injunction.