22 May 2014, BioSpectrum Bureau , BioSpectrum
Singapore: The US drug regulator, the Food and Drug Administration said in a warning letter that Sun Pharmaceutical Industries' response to an import ban on one of its plants lacked "sufficient corrective actions."
The report stated that the 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.