Dr. Reddy’s Srikakulam facility gets 3 U.S. FDA observations
Dr. Reddy’s Laboratories received three observations from the U.S. FDA following an inspection of its Srikakulam manufacturing facility. The company stated it will address these findings within the required timeframe.
Why it matters
Regulatory observations can impact a pharmaceutical company's ability to export products to the U.S. market and affect investor confidence.
Dr. Reddy’s Laboratories has been issued three observations by the U.S. Food and Drug Administration (U.S. FDA) after an inspection of its facility in Srikakulam, Andhra Pradesh.
The U.S. FDA has completed a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection at the FTO-SEZ Process Unit-02 in Srikakulam. The inspection was conducted between July 20 and July 29, the Hyderabad-based generic drugmaker said in a filing on Wednesday (July 29, 2026).
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