FDA WARNING_LETTER - FAREVA AMBOISE - September 16, 2025

The FDA issued a warning letter to Fareva Amboise following an inspection from September 8 to 16, 2025, at its facility in France. The agency identified significant violations of Current Good Manufacturing Practice (CGMP) regulations, leading to the conclusion that the firm"s drug products are adulterated under the Federal Food, Drug, and Cosmetic Act. Key issues included major failures in aseptic processing, such as inadequate airflow studies that failed to demonstrate sterile conditions and poor personnel behavior that compromised product safety. The inspection also found that equipment design hindered proper sterilization, and physical residues were discovered on supposedly clean machinery. Furthermore, the firm exhibited serious data integrity lapses, as electronic systems allowed for the unauthorized modification or deletion of environmental monitoring data, and failing results were not always documented. To resolve these violations, Fareva Amboise must submit a comprehensive remediation plan. This includes performing new dynamic airflow visualizations, conducting a thorough risk assessment of all contamination hazards, and implementing stricter controls over computer systems and data governance. The FDA warned that failure to correct these deficiencies promptly could lead to the withholding of new drug approvals or the refusal of products entering the United States.