Ipca Laboratories' Tarapur facility receives three US FDA observations

Ipca Laboratories announced today that the US Food and Drug Administration (FDA) conducted an inspection of its Active Pharmaceutical Ingredients (APIs) manufacturing facility located in Tarapur, Palghar-Maharashtra. The inspection took place from December 1st to December 5th, 2025.

At the conclusion of the inspection, the US FDA issued a Form 483, noting three observations. Ipca Laboratories has stated its commitment to submitting a comprehensive response to these observations to the US FDA within the stipulated timeframe and will work closely with the agency to resolve the identified issues promptly.

The company emphasized the importance it places on quality and compliance, reaffirming its dedication to maintaining the highest standards across all its manufacturing facilities.