The company's "active pharmaceutical ingredient (API) manufacturing site at Cuddalore was recently inspected by the United States Food and Drug Administration (USFDA)", Strides Shasun said in a filing to the BSE.
This was a routine GMP (good manufacturing practices) inspection and the company successfully completed the inspection with zero 483 observations, it added.
As per USFDA, an "FDA form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts".