# FDA 483 - Contamac Limited - April 03, 2025

Source: https://www.globalkeysolutions.net/records/483/contamac-limited/fe9f8857-0f31-43aa-ac5c-0eb99558b379

> FDA 483 for Contamac Limited on April 03, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Contamac Limited
- Inspection Date: 2025-04-03
- Product Type: device
- Office Name: Office of Inspections and Investigations
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/james-p-finn/70e5c36c-2711-449b-bf73-e08b4dd58449)

Company: https://www.globalkeysolutions.net/companies/contamac-limited/3f3833ca-1719-45b7-a8b3-669e245893f2

Office: https://www.globalkeysolutions.net/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8