With three observations
Granules India announced that its wholly owned foreign subsidiary, Granules Pharmaceuticals Inc., located in Chantilly, Virginia, USA had undergone a Preapproval Inspection (PAI) by the US Food and Drug Administration (USFDA) from 24 to 28 January 2022.The audit is a PAI for two of its product applications filed from this facility. The USFDA issued three minor observations during the audit conducted at the facility.
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