FDA 483 - Minteq UK Limited - August 29, 2025
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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.
ID · 250e2c61-d30e-490d-8e79-e8463a7a972c