Granules plant gets 3 observations after U.S. FDA inspection
Drugmaker Granules facility in Gagillapur, Hyderabad has received three observations on completion of an inspection by the U.S. Food and Drug Administration (U.S. FDA).
“The Gagillapur facility has completed the U.S. FDA’s pre-approval inspection (PAI) from January 9-13 with three observations. The company will respond to the observations within the stipulated time period,” Granules said in a filing with the stock exchange on Saturday. The facility manufactures finished dosages (FDs) and pharmaceutical formulation intermediates (PFIs), it said.