FDA 483 - Ipca Laboratories Limited - June 23, 2023

The FDA inspection of Ipca Laboratories Limited in Dhar, Madhya Pradesh, revealed critical deficiencies in quality control and manufacturing practices. The firm failed to thoroughly investigate out-of-specification results, lacked established time limits for production phases, and used unverified testing methods. Additionally, issues included poorly maintained equipment, inadequate laboratory controls, non-compliant personnel gowning, and ineffective handling of product complaints, indicating a systemic failure to adhere to cGMP regulations.