FDA 483 - Allergan Industrie SAS - March 29, 2007

Corneal Industrie, a medical device manufacturer in Pringy, France, received a Form FDA 483 citing significant deficiencies in its quality system. The inspection revealed widespread issues with Medical Device Reporting (MDR) processes, including improper form usage, delayed reporting of serious injuries, and incomplete report information. Additionally, the firm failed to effectively implement and document corrective and preventive actions (CAPA), and exhibited shortcomings in complaint handling, document approval, and design control procedures.