FDA 483 - Zydus Lifesciences Limited - March 10, 2022

An FDA inspection of Cadila Healthcare Limited, a sterile drug manufacturer in Jarod, Gujarat, India, revealed significant deficiencies. The firm failed to adhere to its written stability testing program and did not complete Annual Product Quality Reviews within established timelines. Additionally, the compounding room for sterile injectable drugs was not maintained in a good state of repair, presenting a potential contamination risk.