Drugmaker Granules said Tuesday that its wholly-owned US subsidiary Granules Pharmaceuticals Inc (GPI)’s Virginia facility has received a facility inspection report (EIR) from the US Food and Drug Administration (USFDA).
The facility was inspected by the US FDA on January 24-28 for two of their submitted product applications. There were three minor observations during the inspection and GPI processed the observations within the stipulated timeframe, Granules said in a release. “We are happy to have completed another audit having successfully addressed minor observations. This is the sixth successful USFDA audit for this facility,” said GPI Executive Director Priyanka Chigurupati.