FDA 483 - Fareva Amboise - September 16, 2025

During an inspection from September 8-16, 2025, the FDA issued a Form 483 to Fareva Amboise, a sterile and non-sterile drug manufacturer in France, citing significant deviations from current Good Manufacturing Practices (cGMP). The inspection revealed critical issues impacting drug product safety, identity, strength, quality, and purity. Key violations included inadequate validation of aseptic processes, with flawed airflow studies and media fills that didn't accurately represent commercial operations, leading to potential microbiological contamination of sterile products. Poor aseptic techniques were observed, such as operators reaching into sterile areas without proper disinfection and placing non-sterile items near critical zones. Furthermore, cleaning and maintenance of non-dedicated equipment were ineffective, as evidenced by active pharmaceutical ingredient (API) residues found post-cleaning and damaged equipment surfaces. The firm lacked robust production and process controls, including deficient visual inspection qualification for particulate matter and absent process validation data for tablet compression settings. Serious data integrity concerns were identified, with electronic systems allowing unauthorized data manipulation and deletion, and a lack of audit trails or proper record reconciliation. Environmental monitoring and disinfection practices in aseptic areas were also found to be inadequate, and batch records lacked essential intervention details and inspector identities. Fareva Amboise is required to implement comprehensive corrective actions to address these systemic failures, ensuring compliance with FDA regulations and preventing contamination or quality issues in their drug products.