Dr. Reddy’s Laboratories announced that the United States Food & Drug Administration (USFDA) has completed a GMP inspection at its formulations manufacturing facility (FTO-3) located in Bachupally, Hyderabad. The inspection took place from August 6, 2026, to August 14, 2026. The company has received a Form 483 with four observations, which it plans to address within the stipulated timeline.
USFDA Inspection Completed at Bachupally Facility
Dr. Reddy’s Laboratories Limited has reported the conclusion of a Good Manufacturing Practices (GMP) inspection conducted by the United States Food & Drug Administration (USFDA). The inspection focused on the company’s formulations manufacturing facility, designated as FTO-3, situated in Bachupally, Hyderabad. This critical regulatory review spanned from August 6, 2026, through August 14, 2026.
Observations and Next Steps
Following the inspection, Dr. Reddy’s Laboratories has been issued a Form 483, which outlines four specific observations. The company has affirmed its commitment to addressing these observations diligently and within the regulatory timelines. This proactive approach is crucial for maintaining compliance and ensuring the continued smooth operation of its manufacturing capabilities for the U.S. market.
Source: BSE
