Hyd-based Dr Reddy’s gets 2 observations from USFDA for New York API plant

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

New Delhi: 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.

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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.