483
Minteq UK LimitedFDA 483 - Minteq UK Limited - August 29, 2025
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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.
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ID · a3c34e31-85cf-4b7e-9a76-e020c6bb6e3c