US FDA postpones foreign inspections over coronavirus outbreak
According to Stephen M Hahn, Commissioner of Food and Drugs - Food and Drug Administration, the foreign inspections will resume as…
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Browsing Tag
inspection
Lupin’s Nagpur facility receives EIR from the US FDA
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
The regulator issued one observation after the inspection, as per reports
Inspection of Unichem’s Kolhapur facility by USFDA completed without observations
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
No Form 483 was issued at the end of the inspection, the company said in a regulatory filing, the company said