Dr Reddy’s Laboratories on Saturday (May 17, 2025) said the U.S. health regulator has issued a Form 483 with two observations after inspecting its U.S.-based facility.
The U.S. 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 – May 17, 2025 11:01 pm IST
Source: https://www.thehindu.com/business/dr-reddys-gets-two-observations-from-usfda-for-new-york-api-plant/article69588529.ece
