Dr Reddy's Gets 4 USFDA Observations for FTO-3 Hyderabad Facility
Hyderabad: Dr. Reddy's Laboratories Limited has received four observations from the United States Food and Drug Administration (USFDA) following the completion of a Good Manufacturing Practices (GMP) inspection at the company's formulations manufacturing facility FTO 3 in Bachupally, Hyderabad.
The USFDA conducted the GMP inspection at the facility from August 6, 2026, to August 14, 2026. At the conclusion of the inspection, the regulatory authority issued a Form 483 containing four observations to the company.
Dr. Reddy’s Laboratories stated that it will address the four observations within the stipulated timeline.
The inspection was specifically carried out at FTO 3, the company’s formulations manufacturing facility located in Bachupally, Hyderabad. The inspection period covered nine days, beginning on August 6 and concluding on August 14, 2026.
A Form 483 was issued following the inspection, with four observations recorded by the USFDA. The company has stated that it will respond to and address these observations within the stipulated timeline.
Dr. Reddy’s Laboratories has stated that it will address all four USFDA observations within the stipulated timeline following the GMP inspection of its FTO 3 formulations manufacturing facility in Bachupally, Hyderabad.
