FDA 483 - AJL Ophthalmic S.A - April 19, 2024

Ajl ophtalmic S/A, a contract manufacturer of INTACS Prescription Inserts/Corneal Implants, was inspected by the FDA and received a Form 483 with six observations. The inspection revealed significant deficiencies in process validation, corrective and preventive actions, complaint handling, medical device reporting, device history records, and rework procedures. These issues indicate a lack of adequate quality system controls for medical device manufacturing.