FDA 483 - Contamac Limited - April 03, 2025

Contamac Limited, a manufacturer of contact lenses in Saffron Walden, Essex, United Kingdom, was cited for deficiencies related to its Quality Management System. The inspection revealed that the firm failed to adequately establish requirements for suppliers and had not conducted internal quality audits for its newly implemented system. These issues indicate a lack of proper oversight for critical suppliers and internal processes.