By: IPP Bureau
Last updated : June 16, 2023 10:16 am
The company will submit its comprehensive response on these observations to the US FDA
Ipca Laboratories gets Form 483 for API manufacturing facility at Ratlam
Ipca Laboratories Limited has announced that the US FDA conducted the inspection of the Company's APIs manufacturing facility situated at Ratlam, Madhya Pradesh from 5th June, 2023 to 13th June, 2023. At the conclusion of the inspection, the US FDA issued a Form 483 with 11 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.