FDA 483 - Ipca Laboratories Limited - August 23, 2019

The FDA inspection of Ipca Laboratories Limited in Silvasa, India, revealed significant deficiencies in the firm's Quality Unit and adherence to current Good Manufacturing Practices (cGMP). Key issues included inadequate investigation of unknown peaks in laboratory tests, deviations from standard operating procedures, and an incomplete electronic data assessment that compromised data integrity. The firm also failed to thoroughly investigate out-of-specification and out-of-trend results, and exhibited systemic delays in closing product complaints, change controls, and CAPAs, indicating a severe breakdown in quality management.