FDA 483 - DOH Central Pharmacy - July 28, 2025

An FDA inspection of DOH Central Pharmacy, a unit dose repacker in Tallahassee, FL, revealed significant deficiencies across multiple quality systems. Observations included inadequate quality control unit procedures, lack of equipment cleaning validations and proper record-keeping, unsupported expiration dates for repackaged drugs, and insufficient sampling of components and complaint handling. These issues indicate a need for comprehensive improvements in the firm's manufacturing and quality assurance practices.