FDA 483 - Unichem Laboratories Limited - July 31, 2019

Unichem Laboratories Limited in Bardez, Goa, India, was inspected by the FDA from July 22-31, 2019. The inspection revealed significant deficiencies across manufacturing process controls, data integrity, sanitation practices, and computer system security. Issues included a lack of validated manufacturing processes, inadequate data backup procedures, failure to follow written sanitation SOPs, and unauthorized changes to critical system setpoints.