New Delhi: Pharma firm Granules through a recent regulatory filing announced its US subsidiary has received two observations from the US health regulator following the completion of the inspection. “Granules Pharmaceuticals Inc, a wholly-owned foreign subsidiary of the company located in Chantilly, Virginia, US has completed USFDA (US Food and Drug Administration) inspection from October 22-26, 2018 with two Form 483 observations,”.
Granules Pharmaceuticals, Inc will respond to the observations within this week, the company added.
As per the USFDA, a Form 483, is issued to a firm’s management at the conclusion of an inspection when investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
“This was a prior approval inspection, intended for the Abbreviated New Drug Application (ANDAs) filed by Granules Pharmaceuticals Inc. This facility is involved in development and manufacturing of finished dosages,” the company said.