FDA EIR - Shawneetown Feed & Seed Co - July 02, 2019

An FDA inspection was conducted at Shawneetown Feed & Seed Co., Inc. on July 2, 2019, to assess compliance with the Part 507 Current Good Manufacturing Practice (cGMP) for Animal Food regulations (21 CFR Part 507). Although no Form FDA 483 observations were issued for the cGMP portion during this initial surveillance, several objectionable conditions were identified. Key issues included excessive accumulations of processed grain, dust, and water in the basement, which could attract pests; significant product build-up on the interior walls of conveyers leading to feed mixers; the presence of older, damaged, and unclean utensils stored near the manufacturing area; and the lack of shielding or shatter-resistant bulbs for lighting fixtures in exposed feed areas. Furthermore, an open container of cat food was discovered in the drug room, posing a potential cross-contamination risk, and the firm’s hazard analysis lacked preventative controls, meaning recall procedures were not implemented. Management committed to voluntary corrections for all discussed observations, including improving housekeeping, enhancing cleaning protocols, replacing unsuitable equipment, installing appropriate lighting, and relocating the cat food. The inspection concluded with a Voluntary Action Indicated (VAI) classification, expecting these corrections to be implemented.