Lupin’s Nagpur facility receives EIR from the US FDA EP News Bureau Oct 18, 2019 The inspection for the oral solid facility at Nagpur closed without any Form 483 observation
US FDA issues one observation for Aleor Dermaceuticals’ Karakhadi unit Press Trust of India Sep 23, 2019 The regulator issued one observation after the inspection, as per reports
Inspection of Unichem’s Kolhapur facility by USFDA completed without observations Press Trust of India Sep 20, 2019 The inspection was a CGMP surveillance and a pre-approval inspection and was successfully concluded without any FDA Form 483…
US FDA completes audit of Dr Reddy’s Louisiana-based facility Press Trust of India Aug 9, 2019 No Form 483 was issued at the end of the inspection, the company said in a regulatory filing, the company said