US health regulator issues 2 observations after inspecting Dr Reddy’s New York plant

US Food and Drug Administration completed a Good Manufacturing Practice inspection at the company’s active pharmaceutical ingredients plant at Middleburgh in New York

• India Weekly
• 17 May, 2025

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By: India Weekly

HYDERABAD-BASED generics drug manufacturer Dr Reddy’s Laboratories on Saturday (17) 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 from May 12-16, Dr Reddy’s said in a regulatory filing.

“We have been issued a Form 483 with two observations, which we will address within the stipulated timeline,” the 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.

Earlier in February, the US health regulator had found some issues at Dr Reddy’s API manufacturing facility in Bollaram, Hyderabad, directed the company to sort them out.