Dr Reddy’s unit gets 3 USFDA observations

Hyderabad: Drug major Dr Reddy’s Laboratories on Tuesday said the US health regulator has made three observations after completing inspection of its Miryalaguda facility in Telangana.

Dr Reddy’s said in a communiqué to BSE, said: “The audit of the company’s API manufacturing plant at Miryalaguda, by the USFDA, has been completed on February 21, 2017.

The company has been issued a Form 483 with three observations, which is being addressed.” According to 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 judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.”