FDA 483 - Excelvision - January 22, 2026

Excel Vision, located in Annonay, France, underwent an FDA inspection from January 12 to January 22, 2026. This Form 483 details significant systemic failures in the company’s sterile drug manufacturing processes. The primary violation involves the firm’s failure to investigate sterility failures and market complaints regarding mold and discoloration. Investigators found that the company frequently attributed contamination to customer handling without evidence, while ignoring 28 documented water leaks into sterile areas and persistent mold growth within the facility. Additional issues include severe facility deficiencies such as cracked floors, rusted equipment, and non-cleanable surfaces in aseptic rooms. Regulatory observers also noted poor aseptic techniques by staff, inadequate airflow validation (smoke studies), and critical equipment that was disinfected rather than sterilized between batches. Data integrity was a major concern, as manufacturing software lacked individual user accounts or audit trails, and maintenance records were kept on unofficial forms. These findings indicate a failure to comply with Current Good Manufacturing Practice (CGMP) standards. Excel Vision is required to respond to these observations with a comprehensive corrective and preventive action (CAPA) plan, addressing how they will remediate the environment and strengthen their quality oversight to ensure product safety.