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 four Form 483 observations to Granules India subsidiary Granules Pharmaceuticals Inc facility in Virginia, US.

It was a routine current Good Manufacturing Practices (cGMP) audit. The observations are related to procedural matters and no data integrity–related observations were reported during the inspection.

The inspection was conducted from March 30-April 3 and the second U.S. FDA inspection at the Chantilly facility in last one year, the parent company said in a filing on Saturday.