FDA 483 - Smithfield Bioscience Inc - December 23, 2025

Smithfield Biosciences, Inc. in Cincinnati, OH, an API manufacturer, received a Form 483 with six observations during an inspection from December 16-23, 2025. The inspection revealed significant deficiencies in process validation, supplier qualification, quality unit review of records, investigation of discrepancies, personnel adequacy, and the stability program. These issues indicate a lack of robust quality control and compliance with GMP requirements for API manufacturing.