USFDA Issues Form 483 With 3 Observation To IPCA's Piparia Unit
On Thursday, Mumbai-based IPCA Laboratories informed in an exchange filing that the USFDA conducted the inspection of the company's formulations manufacturing unit situated at Piparia (Silvassa) from 18th April 2023 to 26th April 2023.
The company stated that at the conclusion of the inspection, the USFDA issued a Form 483 with 3 (three) observations. As per the USFDA, an FDA Form 483 is issued to a company at the end of an inspection when an investigator observes any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
The company said that it will submit its comprehensive response to 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 maintaining the highest standards of quality and compliance across all its facilities," the company said in the regulatory filing.
IPCA's stock was trading 1.12 per cent higher on Friday at Rs 709 per scrip on BSE as of 11:08 AM IST.
