FDA 483 - Holmes By Products Co Inc - March 29, 2024

Holmes By Products Co Inc, an animal food manufacturer in Millersburg, OH, was cited for multiple deficiencies in its hazard analysis and preventive controls during an FDA inspection. Observations included failure to identify tissue residue hazards from deadstock, inadequate foreign material controls, and insufficient procedures for CMPAF removal and process control monitoring. The firm also lacked proper record review, calibration procedures, and customer disclosures regarding identified hazards.