Granules Pharmaceuticals concludes USFDA audit with three minor observations

The audit is a PAI for two of its product applications filed from this facility

Granules India announced that Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of the company, located in Chantilly, Virginia, USA had undergone a Pre-approval Inspection (PAI) by the US Food and Drug Administration (US FDA) from 24th to 28th January 2022.

The audit is a PAI for two of its product applications filed from this facility. The US FDA issued three minor observations during the audit conducted at the facility.

Commenting on the audit, Priyanka Chigurupati, Executive Director, GPI, said, “We are glad to have completed yet another audit with minor observations that we will respond to within the stipulated time period.”