New Delhi: Pharma firm Granules India on Wednesday said the US health regulator has issued Establishment Inspection Report (EIR) after an audit of its Telangana facility.
“The United States Food and Drug Administration (USFDA) has issued Establishment Inspection Report (EIR) for the company’s Jeedimetla facility located at Hyderabad, Telangana, India,” Granules said in a BSE filing.
The company said this facility was inspected by the USFDA in March 2018 and there was one observation during the inspection. Granules said it has responded to the observation within the stipulated time frame.
Jeedimetla facility manufactures active pharmaceutical ingredients (APIs) and pharmaceutical formulation intermediates (PFIs), the company added.
The USFDA issues an EIR to the establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection.