FDA EIR - Grain Processing Corporation - August 29, 2017

Grain Processing Corporation, located in Muscatine, IA, underwent a comprehensive FDA surveillance inspection on August 29, 2017. The inspection, conducted under regulatory frameworks including 21 CFR 507 for animal feed Good Manufacturing Practices (cGMPs), focused on the company's human food and animal feed ingredient manufacturing operations. Two key observations were identified. First, the company did not effectively protect bulk animal feed stored outdoors from contamination, as evidenced by accumulated residue from prior production on an outdoor asphalt storage pad that attracted numerous flying insects and birds. This presented a contamination risk, especially given its proximity to human food ingredient storage. Second, the facility failed to implement effective pest exclusion measures, with flying insects observed inside the human food ingredient warehouse and bagging area, and protective netting on an animal feed dryer building containing substantial openings. During the closeout meeting, management acknowledged these findings and committed to implementing corrective actions. Additional discussions involved correcting standard operating procedure references, mitigating wet areas, and reinforcing overall adherence to the Federal Food, Drug, and Cosmetic Act. While no FDA Form 483 was issued, the observations and management's commitments were formally documented.