First Priority, Inc. – FDA 483, Jul 30, 2024

An FDA inspection of First Priority, Inc., an animal drug manufacturer in Elgin, IL, revealed significant deficiencies in its quality control unit and manufacturing practices. The firm failed to adequately investigate out-of-specification results and complaints, maintain proper documentation, and ensure equipment cleaning validation. Several critical issues, including cleaning validation and field alert reporting, were repeat observations from previous inspections, indicating persistent non-compliance.