Dr Reddy's Gets 7 USFDA Observations for Bachupally Biologics Plant
New Delhi: Dr. Reddy's Laboratories Limited has informed the stock exchanges that the United States Food and Drug Administration (USFDA) has completed a Pre-License Inspection (PLI) at the company's biologics manufacturing facility located in Bachupally, Hyderabad, and has issued a Form 483 containing seven observations.
According to the filing, the USFDA conducted the Pre-License Inspection between June 16 and June 25, 2026, and completed the inspection on June 25, 2026.
Following the conclusion of the inspection, the USFDA issued a Form 483 with seven observations to the company. However, the filing does not disclose the nature or details of the observations made by the US drug regulator. Dr. Reddy's Laboratories stated that it will address all seven observations within the stipulated timeline prescribed by the USFDA.
The company further informed that the latest inspection is a continuation of earlier regulatory inspections at the Bachupally biologics manufacturing facility and referred to its previous disclosures made to the stock exchanges on October 12, 2023, and September 13, 2025, relating to those inspections.
According to the regulatory filing submitted by Dr. Reddy's Laboratories, the USFDA has completed the Pre-License Inspection of the company's biologics manufacturing facility at Bachupally, Hyderabad, following an inspection conducted from June 16 to June 25, 2026. The company received a Form 483 containing seven observations and stated that it will respond to the observations within the prescribed timeline.
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