FDA 483 - Fisiopharma Srl - September 27, 2019

Fisiopharma Srl, a sterile drug manufacturer in Palomonte, Italy, was cited for significant deficiencies across its quality systems during an FDA inspection. Observations included inadequate aseptic process validation, insufficient investigation of discrepancies, unvalidated test methods, and deficient contamination control systems. The firm also lacked proper production control procedures, quality control unit adherence, and annual product review processes, indicating a broad failure to ensure drug product quality and purity.