FDA 483 - Hansen Mueller Company Kansas City - May 03, 2024

An FDA inspection conducted at Hansen Mueller Company Kansas City from April 22 to May 3, 2024, revealed significant deficiencies in the warehouse's animal food handling and sanitation practices. The observations indicate a lack of adherence to regulatory requirements aimed at preventing contamination and ensuring product safety.Key issues included a failure to prevent cross-contamination between mammalian-derived protein (gel bone) and non-mammalian animal food products (soybean meal, DDGs). Investigators observed gel bone material on shared equipment and noted the absence of adequate cleanout procedures or cleaning documentation. Additionally, products potentially contaminated with mammalian protein were not labeled with the required "Do not feed to cattle or other ruminants" caution statement.The inspection also highlighted a critical lack of employee training. Personnel responsible for handling gel bone were not adequately instructed on segregation importance or Bovine Spongiform Encephalopathy (BSE) prevention, and were unfamiliar with their own quality assurance documents. Furthermore, equipment was found poorly maintained, with significant buildup, insects, and mold observed on soybean meal equipment, and gel bone residue on its dedicated transloader, contradicting documented cleaning protocols.The company is required to implement corrective actions to ensure proper segregation, effective cleaning and maintenance, accurate product labeling, and comprehensive employee training to comply with animal food safety regulations and prevent potential harm to animal health.