Dr. Reddy's Laboratories receives USFDA observations at Andhra Pradesh plant

Dr. Reddy's Laboratories has received a USFDA Form 483 containing two observations following a pre-approval inspection (PAI) at its FTO-11 manufacturing facility in Pydibhimavaram, Andhra Pradesh.

The inspection took place from October 5 to October 7, 2026. A Form 483 is issued by inspectors when they identify potential regulatory non-compliance at the conclusion of a visit. As this was a pre-approval inspection, the USFDA was assessing the facility's readiness to manufacture specific products currently awaiting regulatory approval.

The Hyderabad-based pharmaceutical company stated in a regulatory filing that it intends to address the observations within the timeframe stipulated by the regulator. The specific nature of the observations was not disclosed in the company's announcement.