U.S. FDA issues 4 observations to U.S. facility of Granules arm

The U.S. Food and Drug Administration (U.S. FDA) has issued 4 Form 483 observations to Granules India subsidiary Granules Pharmaceuticals Inc installation successful Virginia, US.

It was a regular existent Good Manufacturing Practices (cGMP) audit. The observations are related to procedural matters and nary information integrity–related observations were reported during the inspection.

The inspection was conducted from March 30-April 3 and the 2nd U.S. FDA inspection astatine the Chantilly installation successful past 1 year, the genitor institution said successful a filing connected Saturday.