USFDA issues 3 minor observations to Granules India arm in pre-approval inspection

Drugmaker Granules India Ltd on Monday said the US health regulator has issued "three minor observations" to its wholly-owned arm Granules Pharmaceuticals, Inc (GPI) in a pre-approval inspection (PAI). Granules Pharmaceuticals located in Chantilly, Virginia, US, had undergone a PAI by the US Food and Drug Administration (USFDA) from January 24-28, 2022, the company said in a statement.

"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," it added, without elaborating on the nature of the observations.

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