The United States Food and Drug Administration (USFDA) has conducted the inspection at Ipca Laboratories’ APIs manufacturing facility situated at Ratlam, Madhya Pradesh from June 5, 2023 to June 13, 2023. At the conclusion of the inspection, the USFDA issued a Form 483 with 11 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.
