FDA WARNING_LETTER - Excelvision - Fareva - January 22, 2026

In a warning letter dated June 25, 2026, the FDA detailed significant manufacturing violations at the Excelvision - Fareva facility in Annonay, France. Following an inspection from January 12 to 22, 2026, the agency determined that the company’s drug products are adulterated because they were not manufactured in compliance with current Good Manufacturing Practice (CGMP) regulations under the Federal Food, Drug, and Cosmetic Act. A primary concern was the firm’s failure to investigate recurring reports of contamination in sterile products. Despite customers reporting mold and debris in medications, Excelvision often attributed the issues to consumer handling without scientific proof. Inspectors also observed poor aseptic techniques, such as staff blocking filtered airflow and failing to properly disinfect sterile areas. Additionally, the facility was poorly maintained, with non-waterproof surfaces and a history of water leaks in cleanrooms. The firm also failed to sterilize critical equipment that directly contacts sterile components. To address these systemic issues, the FDA requires Excelvision to hire an independent consultant to audit their operations and oversee a comprehensive quality system overhaul. The company must provide detailed remediation plans, conduct a retrospective review of all contamination incidents, and evaluate the integrity of its packaging systems. While Excelvision has committed to suspending certain production lines for the U.S. market, the FDA must be notified and provided with evidence of effective corrective actions before manufacturing can resume.