FDA 483 - Centaur Pharmaceuticals Private Limited - January 13, 2023

Centaur Pharmaceuticals Private Limited, a non-sterile drug manufacturer in Tuem, Goa, India, was inspected by the FDA from January 9-13, 2023. The inspection revealed significant deficiencies in laboratory controls, stability testing, microbial control procedures, and cleaning validation. These issues collectively indicate a need for comprehensive improvements in their quality control and production processes to ensure drug product identity, strength, quality, and purity.