Dr Reddy's NY API plant gets USFDA Form 483 with 2 observations
Dr. Reddy's- building
HYDERABAD: Pharma major Dr Reddy's Laboratories on Saturday said its
active pharmaceutical ingredients
manufacturing facility
at
Middleburgh
in New York has been issued a Form 483 with two observations by the US drug regulator, US Food and Drug Administration (US FDA).
'We have been issued a Form 483 with two observations, which we will address within the stipulated timeline,' Dr Reddy's said in a
regulatory filing
.
The Hyderabad-based company said the good manufacturing practices (GMP) inspection was conducted by US FDA between May 12, 2025, and May 16, 2025, the company said.
A Form 483 is issued by USFDA inspectors to the management of the company at the end of an onsite inspection if inspectors find any violations of the Food, Drug and Cosmetic (FD&C) Act or other regulations, as per USFDA.
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