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May 19, 2025 at 10:09 AM IST
Dr. Reddy’s Laboratories Ltd. said on Saturday that the US Food and Drug Administration (FDA) issued Form 483 with two observations following a five-day inspection of its active pharmaceutical ingredients (API) facility in Middleburgh, New York. The inspection was conducted from May 12 to May 16, the company said in an exchange filing.
The company added that it will respond to the observations and resolve the issues within the prescribed timeframe.