FDA 483 - Intas Pharmaceuticals Limited - June 08, 2018

An FDA inspection of Intas Pharmaceuticals Limited in Ahmedabad, Gujarat, India, conducted from May 31 to June 8, 2018, identified significant observations related to their sterile drug manufacturing operations. The findings, documented on an FDA Form 483, highlighted two main areas of concern. Firstly, deficiencies were noted in the environmental control systems for sterile processing, including inadequate studies for barrier systems, inappropriate media fill protocols for certain vial types, insufficient data correlating sterilization processes with monitoring detectors, and incomplete procedures for microbial monitoring of gloves. Secondly, the firm failed to thoroughly investigate unexplained discrepancies and equipment failures. Specific examples included four instances where investigations into issues such as power fluctuations, shorted wires, or broken equipment components did not adequately determine the root cause or propose sufficient corrective and preventative actions. Intas Pharmaceuticals is expected to address these observations to ensure full compliance with regulatory standards for pharmaceutical manufacturing.