Dr Reddy's Gets USFDA Observations for New York API Plant

May 17, 2025 15:17

Dr Reddy's Laboratories received two observations from the USFDA following an inspection of its API facility in New York. The observations were related to Good Manufacturing Practices (GMP).

New Delhi, May 17 (PTI) 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.

Source: PTI

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Dr Reddy's Gets USFDA Observations for New York API Plant

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