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

Source: https://www.globalkeysolutions.net/records/483/minteq-uk-limited/a3c34e31-85cf-4b7e-9a76-e020c6bb6e3c

> 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: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: An FDA inspection of Minteq UK Limited in Birmingham, United Kingdom, an API manufacturer, revealed ten significant deficiencies in their quality management system. Observations included failures in quality unit responsibilities, raw material identity testing, data integrity, and various GMP procedures. These issues indicate a lack of robust controls and training necessary for compliant API manufacturing.

## Related Documents

- [483 - 2025-08-29](https://www.globalkeysolutions.net/records/483/minteq-uk-limited/250e2c61-d30e-490d-8e79-e8463a7a972c)

## 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/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd