FDA 483 - Laboratorio Italiano Biochimico Farmaceutico Lisapharma SPA - March 01, 2022

An FDA inspection of Laboratorio Italiano Biochimico Farmaceutico Lisapharma SPA in Erba, Italy, revealed significant deficiencies in aseptic processing and quality control for sterile drug manufacturing. Observations included inadequate procedures to prevent microbiological contamination, ineffective cleaning and disinfection, and failures in investigating discrepancies and maintaining complete laboratory records. These issues indicate a need for comprehensive improvements in the firm's quality systems to ensure the sterility and quality of its injectable drug products.