FDA 483 - Fareva Amboise - September 16, 2025

Fareva Amboise, a sterile and non-sterile drug manufacturer in Poce Sur Cisse, France, was cited for significant deficiencies during an FDA inspection. Observations included inadequate aseptic process validation, poor aseptic techniques, ineffective cleaning and maintenance of equipment, and insufficient production and process controls. Furthermore, the firm demonstrated a lack of data integrity controls, inadequate environmental monitoring, and incomplete batch and master production records.