Dr Reddy's New York Facility Receives FDA Observations

Dr Reddy's Laboratories reported Saturday that the US Food and Drug Administration (FDA) has issued a Form 483, highlighting two observations following an inspection of its facility in New York.

The inspection, part of a Good Manufacturing Practice (GMP) compliance check, was conducted at the company's active pharmaceutical ingredients (API) facility in Middleburgh, overseen by the FDA during the week of May 12-16, 2025.

According to the FDA, Form 483 documents any conditions that may violate the Food Drug and Cosmetic Act. Dr Reddy's, based in Hyderabad, has confirmed that it will address the observations within the required timeframe.

(With inputs from agencies.)