FDA 483 - DOH Central Pharmacy - July 28, 2025
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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.
- Office
- Florida District Office
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ID · 2e63bbe8-378e-4bfb-9291-b4cd93a9a372