By: IPP Bureau
Last updated : June 24, 2023 8:34 am
The company will submit its comprehensive response on these observations to the USFDA
The US FDA conducted the inspection of Ipca Laboratories Limited's formulations manufacturing facility situated at SEZ Indore, Pithampur (Madhya Pradesh) from 15th June, 2023 to 23rd June, 2023. At the conclusion of the inspection, US FDA has issued a Form 483 with 8 (eight) observations.
The company will submit its comprehensive response on these observations to the US FDA 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.