FDA 483 - Packpharm Limited - September 01, 2023

Packpharm Limited in Norwich, United Kingdom, was inspected by the FDA, revealing significant deficiencies across laboratory controls, manufacturing process validation, and facility maintenance. The firm failed to establish adequate specifications for drug product impurities and dissolution, did not properly qualify equipment for manufacturing, and maintained a warehouse in a poor state of repair with observed stains, cracks, and insects. These issues indicate a lack of robust quality systems to ensure drug product quality and facility integrity.