Dr Reddy's Gets Two Observations From US FDA For New York API Plant

Dr. Reddy's Laboratories Ltd. 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 inspection at the company's active pharmaceutical ingredients Middleburgh facility in New York, Dr Reddy's Laboratories 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 Act and related Acts.