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USFDA closes observations on Granules India’s arm

Our Bureau Hyderabad | Updated on July 21, 2021

Earlier, it had issued two minor observations during the audit.

The US Food and Drug Administration (USFDA) has closed its observations on Granules Pharmaceuticals, Inc. (GPI), a wholly-owned foreign subsidiary of Granules India Ltd in Chantilly, Virginia, USA.

The facility had undergone a pre-approval inspection audit by the regulator from June 21-25, 2021. The audit is a pre-approval inspection for three of its applications filed from this facility. The FDA issued two minor observations during the audit.

“The observations were responded to within the stipulated time, and the FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on July 20, 2021. This is the fifth US FDA audit for this facility” Priyanka Chigurupati, Executive Director, GPI, said in a release.

Published on July 21, 2021

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