USFDA13 Sept 2025, 11:00 am
Dr Reddys Laboratories Receives USFDA Form 483 with Five Observations at Biologics Manufacturing Facility in Bachupally, Hyderabad
AI Summary
Dr Reddys Laboratories Ltd has announced that the United States Food & Drug Administration (USFDA) completed a Pre-Approval Inspection (PAI) at their biologics manufacturing facility in Bachupally, Hyderabad on September 12, 2025. The inspection took place from September 4, 2025 to September 12, 2025, resulting in the issuance of a Form 483 with five observations. The company is committed to addressing these observations within the stipulated timeline, following an earlier inspection and disclosure made to the stock exchanges on October 12, 2023.
Key Highlights
- Dr Reddys Laboratories underwent a Pre-Approval Inspection (PAI) by the USFDA at their biologics manufacturing facility in Bachupally, Hyderabad
- The USFDA inspection took place from September 4, 2025 to September 12, 2025
- A Form 483 was issued by the USFDA with five observations
- The company is obligated to address the observations within the given timeline
- This disclosure is pursuant to an earlier USFDA inspection and disclosure made in October 2023