Ipca Laboratories has informed that the US FDA conducted the inspection of the Company’s formulations manufacturing unit situated at Piparia (Silvassa) from 18th April, 2023 to 26 April, 2023. At the conclusion of the inspection, the US FDA issued a Form 483 with 3 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 facilities.
The above information is a part of company’s filings submitted to BSE.
