FDA WARNING_LETTER - Excelvision - November 19, 2024

The FDA inspected Excelvision's drug manufacturing facility in Annonay, France, from November 12-19, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR parts 210 and 211, rendering their drug products adulterated. The firm failed to thoroughly investigate unexplained discrepancies or failures to meet specifications (21 CFR 211.192), particularly regarding customer complaints of mold, black specks, and discoloration in sterile drug products. Investigations were deemed inadequate, lacking scientific root cause determination and effective corrective actions, despite a history of mold recovery in manufacturing areas. Furthermore, Excelvision failed to establish and follow appropriate written procedures to prevent microbiological contamination and validate aseptic processes (21 CFR 211.113(b)). This was evidenced by inadequate airflow visualization studies showing turbulent airflow and observed poor aseptic techniques during manual interventions. The firm also lacked an adequate system for cleaning, disinfecting, and maintaining equipment for aseptic conditions (21 CFR 211.42(c)(10)(v) and 211.42(c)(10)(vi)), with critical equipment components not sterilized and documented equipment damage (scratches/cracks) remaining unaddressed. The FDA found the firm's responses inadequate, requiring comprehensive investigations, effective CAPA plans, improved aseptic processing controls, and a risk assessment for product sterility. The company has committed to ceasing production on traditional fill lines. Failure to promptly correct these systemic flaws could lead to FDA withholding approvals, re-inspection, and refusal of admission of products into the U.S. A written response detailing corrective actions is required within 15 working days.