FDA 483 - Appleton City Feed Service LLC - April 12, 2024

An FDA inspection conducted at Appleton City Feed Service LLC from March 19 to April 12, 2024, identified several significant issues related to medicated animal feed manufacturing and food safety practices. The manufacturer was cited for not adhering to approved conditions and labeling for Veterinary Feed Directive (VFD) drugs and combination drugs, a repeat observation. Specifically, the firm produced medicated cattle feed with incorrect drug levels of chlortetracycline and unapproved drug combinations, such as chlortetracycline with monensin, which were not authorized by the VFD orders. Additionally, the company distributed VFD-containing animal feed that did not conform to the directives, including instances where VFD feed was manufactured without a valid VFD. Another critical finding was the failure to implement preventive controls for identified chemical hazards, such as mycotoxins (aflatoxins, fumonisin, deoxynivalenol), in susceptible ingredients like corn and distillers' grains. The firm admitted to not testing for these contaminants and accepted significant quantities of customer-delivered corn without evaluating its suitability. Furthermore, the inspection revealed a lack of qualified personnel; employees involved in animal food manufacturing had not received appropriate training in animal food hygiene and safety, also a repeat observation. The firm also lacked a Preventative Control Qualified Individual (PCQI) with the necessary training or experience to develop and manage a robust Food Safety Plan. Appleton City Feed Service LLC is expected to implement comprehensive corrective actions to address these deficiencies, ensuring compliance with federal regulations governing medicated feed and animal food safety.