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USFDA29 Jul 2026, 09:40 pm

Dr Reddy's USFDA Inspection: 3 Observations Issued

AI Summary

Dr Reddy's Laboratories Ltd announced that the USFDA has completed a Pre-Approval Inspection (PAI) and Good Manufacturing Practices (GMP) inspection at its FTO-SEZ Process Unit-02 in Srikakulam, Andhra Pradesh. The inspection, conducted from July 20 to July 29, 2026, resulted in the issuance of a Form 483 with three observations. The company stated it will address these observations within the stipulated timeline.

Key Highlights

  • USFDA inspection completed at Srikakulam facility.
  • Form 483 issued with three observations.
  • Company to address observations within timeline.
  • Inspection covered PAI and GMP aspects.
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DRREDDY
Pharmaceuticals
DR.REDDY'S LABORATORIES LTD.

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