New Delhi, May 17 – Dr Reddy's Laboratories announced on Saturday that the US Food and Drug Administration (USFDA) has issued a Form 483 with two observations following a recent inspection of its Active Pharmaceutical Ingredient (API) facility in Middleburgh, New York.
The Hyderabad-based pharmaceutical company stated in a regulatory filing that the US health regulator concluded a Good Manufacturing Practice (GMP) inspection at the facility between May 12 and May 16, 2025.
"We have been issued a Form 483 with two observations, which we will address within the stipulated timeline," Dr Reddy's said in its statement.
The USFDA issues Form 483 at the end of an inspection when investigators identify conditions that may potentially violate the Food, Drug, and Cosmetic (FD&C) Act or other related regulations.
The company did not disclose the nature of the observations but assured that it would take corrective measures within the regulatory framework.