USFDA Completes Inspection of Dr. Reddy's Biologics Facility, Issues Form 483

USFDA Completes Inspection of Dr. Reddy's Biologics Facility, Issues Form 483

USFDA Completes Inspection of Dr. Reddy's Biologics Facility, Issues Form 483​

Dr. Reddy's Laboratories Limited has reported that the United States Food & Drug Administration (USFDA) completed a Pre-License Inspection (PLI) at its biologics manufacturing facility located in Bachupally, Hyderabad. The inspection was conducted over two weeks, running from June 16 to June 25, 2026.

Following the completion of the PLI, the company has received Form 483, which contains seven observations regarding the facility processes. Dr. Reddy's Laboratories stated that it will address all observations within the stipulated timeframe.

This inspection marks a continuation of previous reviews conducted by USFDA, including inspections that took place on October 12, 2023, and September 13, 2025. The company remains committed to addressing regulatory feedback while maintaining operations at its key manufacturing site in Hyderabad.

DRREDDY Stock Price Movement​

Dr. Reddy's Laboratories Limited shares surged on Thursday after posting a strong 1.59% gain, settling at ₹1350.5 amid heightened market activity. The equity saw robust trading volume, with approximately 1.7 million shares changing hands as the stock tested near its long-term highs.
 

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