FDA 483 - University Of Pittsburgh Medical Center (Centralized Packaging (CPAK)) - August 14, 2025

An FDA inspection of University of Pittsburgh Medical Center Centralized Packaging in Pittsburgh, PA, identified significant deficiencies in their drug repackaging operations. The firm failed to conduct cleaning validation studies to prevent penicillin cross-contamination, did not thoroughly investigate 750 identified defects, and assigned expiration dates to repackaged drug products without supporting stability data. These issues indicate a lack of adherence to good manufacturing practices.