Contamac LimitedApril 3, 2025

FDA 483 - Contamac Limited - April 03, 2025

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Record Details

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.

Company: Contamac Limited
Inspection Date: April 3, 2025
Product Type: Device
Office: Office of Inspections and Investigations
Person: James P. Finn (investigator)

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ID · fe9f8857-0f31-43aa-ac5c-0eb99558b379