The United States Food and Drug Administration (USFDA) has conducted the inspection at Ipca Laboratories’ Active Pharmaceutical Ingredients (APIs) manufacturing facility situated at Tarapur (Palghar-Maharashtra) from December 1, 2025 to December 5, 2025. At the conclusion of the inspection, USFDA has issued a Form 483 with 3 observations.
The company will submit its comprehensive response on these observations to the USFDA within the stipulated time and shall work closely with the agency to resolve these issues at the earliest. The company takes the quality and compliance issues with utmost importance and remains committed to maintain the highest standards of quality and compliance across all its manufacturing facilities.
Ipca Laboratories is engaged in manufacturing of active pharmaceutical ingredients and formulations.
