Hyderabad-based pharmaceutical company Gland Pharma on Saturday said in an exchange filing that the Office of Medical Device and Radiological Health Operations (OMDRHO), United States Food and Drug Administration (USFDA) conducted pre-market inspection covering US FDA’s Current Good Manufacturing Practice regulations for medical devices.
The company informed that the USFDA inspected the Pashamylaram Facility at Hyderabad from 23 August 2023 to 26 August 2023. The top US regulator has issued two observations on Form 483 with respect to the Abbreviated New Drug Application (ANDA) filed for the product to be manufactured in a pen device at the said facility.
According to the USFDA, an FDA Form 483 is issued to a firm's management at the conclusion of an inspection when an investigator observes conditions that violate the Food Drug and Cosmetic (FD&C) Act and related Acts.
Gland Pharma further said that the company is committed to addressing the observations and will submit its response to the USFDA within the stipulated time.
On Friday the pharma firm's stock closed 1.77 per cent lower at Rs 1,546.35 per scrip on the Bombay Stock Exchange (BSE).