# FDA 483 - Minteq UK Limited - August 29, 2025

Source: https://www.globalkeysolutions.net/records/483/minteq-uk-limited/250e2c61-d30e-490d-8e79-e8463a7a972c

> FDA 483 for Minteq UK Limited on August 29, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Minteq UK Limited
- Inspection Date: 2025-08-29
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: Minteq UK Limited, an API manufacturer in Birmingham, United Kingdom, was cited for numerous significant deficiencies related to its quality unit, procedures, and laboratory controls. The inspection revealed a systemic lack of written procedures, inadequate raw material testing, insufficient data backup, and a failure to ensure proper equipment calibration and employee GMP training. These issues indicate a broad breakdown in the firm's quality management system for API manufacturing.

## Related Documents

- [483 - 2025-08-29](https://www.globalkeysolutions.net/records/483/minteq-uk-limited/a3c34e31-85cf-4b7e-9a76-e020c6bb6e3c)

## Related Officers

- [Jose M. Cayuela](https://www.globalkeysolutions.net/people/jose-m-cayuela/3ee89bb5-4bba-493b-816f-31b8a9768025)

Company: https://www.globalkeysolutions.net/companies/minteq-uk-limited/08f82870-b388-4939-8b90-729be4cd9154

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