There were no 483 observations
LifeSan Clinical Research, a division of Centaur Pharmaceuticals recently underwent an unannounced USFDA inspection. The outcome of this inspection was successful” as there were no 483 observations. This was the 5th successful and unannounced US FDA inspection of LifeSan in the last decade.
LifeSan has successfully faced five inspections from US FDA; 2 from MHRA/ EMA and 1 inspection from MCC, South Africa. LifeSan undertakes bioavailability/ bioequivalence studies, which are mandatory for the generic drug approval process and phase II/III clinical trials.