Dr Reddy’s receives two USFDA observations for API facility in New York

Dr Reddy’s Laboratories has disclosed that the US Food and Drug Administration has issued a Form 483 with two observations following a recent inspection of its active pharmaceutical ingredient manufacturing facility in Middleburgh, New York. 

Dr Reddy’s Laboratories on Saturday said the US health regulator has issued a Form 483 with two observations after inspecting its US-based facility.

The US Food and Drug Administration completed a Good Manufacturing Practice (GMP) inspection at the company’s API (active pharmaceutical ingredients) Middleburgh facility in New York, Dr Reddy’s said in a regulatory filing.

The inspection was conducted during May 12-16, 2025, it added.

“We have been issued a Form 483 with two observations, which we will address within the stipulated timeline,” the Hyderabad-based drug firm said.

As per USFDA, Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.

Published on May 17, 2025