This site is intended for Healthcare professionals only.

Granules gets 2 observation by USFDA for U.S Unit


Granules gets 2 observation by USFDA for U.S Unit

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.

Read Also: Granules India Q1 net profit up 41 percent to Rs 51.7 crore

 



Source: PTI
0 comment(s) on Granules gets 2 observation by USFDA for U.S Unit

Share your Opinion Disclaimer

Sort by: Newest | Oldest | Most Voted