FDA 483 - Centrient Pharmaceuticals India Private Limited - July 01, 2022

An FDA inspection of Centrient Pharmaceuticals India Private Limited, an API manufacturer in Dist. SBS Nagar, revealed significant deficiencies across its operations. The firm exhibited inadequate quality control, poor data integrity, and failures in validating critical manufacturing processes and equipment. These issues collectively indicate a lack of robust quality management and control over the production of active pharmaceutical ingredients.