A division of Centaur Pharmaceuticals Pvt Ltd, LifeSan Clinical Research has obtained zero Form 483 observations from US Food and Drug Administration (FDA). The company has undergone an undeclared US FDA inspection between 5 and 8 August 2019.
The FDA Form 483 is furnished at the end of an on-site inspection if the FDA field investigator has seen deficiencies in the quality system or conditions that breach the Food, Drug or Cosmetic Act.
This was the fifth successful and undeclared USFDA inspection of LifeSan in the last one decade. Following which LifeSan Clinical Research obtained an establishment inspection report (EIR) in the last week of November 2019.
Managing director, Centaur Pharmaceuticals, S D Sawant, stated that the zero 483 scrutiny reports to LifeSan Clinical Research are yet another feather in their cap. They are glad with this vital development not only for Centaur, but also for the pharmaceutical industry of
India. With this audit, Centaur Pharmaceuticals Pvt Ltd is proud to proclaim that their “end-to-end” solution rendering facilities of API, formulation and clinical research, are all successfully audited and accredited by USFDA and other regulatory agency.
