Sun Pharma response to import ban lack sufficient corrective actions: USFDA
May 21, 2014 | Wednesday | News | By BioSpectrum Bureau
Sun Pharma response to import ban lack sufficient corrective actions: USFDA
Sun Pharma failed to impose measures after the ban by USFDA
U.S. Food and Drug Administration said in a warning letter that Sun Pharmaceutical Industries Ltd's response to an import ban on one of its plants lacked "sufficient corrective actions.
Report stated that USFDA banned imports from Sun Pharma's Karkhadi plant in Gujarat in March.
Sun Pharma failed to ensure laboratory records had complete data and that manufacturing staff had inadequate training and experience, FDA was quoted as saying.
The Karkhadi plant, which makes the antibiotic cephalosporin, is one of Sun Pharma's 25 manufacturing plants.
