Institute of Good Manufacturing Practices India®

US health regulator issued three observations for New York API manufacturing plant: Dr Reddy's Lab

Dr Reddy's Laboratories, an integrated pharmaceutical company, said that the US health regulator had issued a Form 483 with three observations after inspection of its manufacturing facility in Middleburg, New York. 

The company's active pharmaceutical ingredients (API) manufacturing plant audit at Middleburg, New York, has been completed by the USFDA, the Hyderabad-based drug major stated in a regulatory filing.

The company will bring them under discussion comprehensively within the stipulated timeline. Currently, the company does not have any sales from this plant.

Form 483 is issued to firm management when any conditions constitute violations of the Food Drug and Cosmetic Act and related acts, on inspection by investigators, as per the USFDA.

Shares of Dr. Reddy's Laboratories came off the day's high after the drugmaker said its API manufacturing plant at New York received three observations from the US drug regulator.