FDA Flags GMP Violations at French Sterile Drug Manufacturer

In November 2024, the U.S. FDA inspected Excelvision Fareva, a French producer of sterile prescription and OTC drugs, uncovering serious GMP deficiencies. Issues included poor complaint handling, microbiological contamination, and inadequate cleaning procedures. Between January 2023 and November 2024, complaints about mold, particles, and discoloration were not thoroughly investigated. Environmental monitoring revealed mold species like Penicillium and Aspergillus, and prior incidents from 2022–2023 were ignored. The FDA also cited airflow problems in ISO 5 areas, poor aseptic practices, and unsterilized components used in the filling line. Equipment damage identified in earlier inspections remained unresolved. Although the company revised its SOPs and initiated some CAPAs, the FDA deemed the response insufficient. Production on the aseptic line has stopped, and an import ban on products from the facility is in effect. A re-inspection may follow to confirm compliance. The full Warning Letter is available on the FDA website.

08-06-2025