“The observations were responded to within the stipulated time, and we are happy to inform that the FDA has closed the observations pertaining to this audit with an Establishment Inspection Report on the 20th of July 2021. This is the fifth US FDA audit for this facility” said Priyanka Chigurupati, Executive Director, GPI.
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.
On Sensex, Granules stock completed at Rs383.75 per piece up by 4.3%.