Dr. Reddy's resolves USFDA inspection with 'Voluntary Action Indicated' classification

Dr. Reddy's Laboratories Ltd. today, October 21, 2025, informed stock exchanges about the receipt of the Establishment Inspection Report (EIR) on October 20, 2025. This followed a GMP and Pre-Approval Inspection (PAI) by the United States Food & Drug Administration (USFDA). The inspection, previously intimated on July 18, 2025, took place at the company’s formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh, India.

The USFDA has classified the inspection outcome as 'Voluntary Action Indicated (VAI)'. This signifies the agency noted observations but considers them minor or correctable without immediate administrative or regulatory action, indicating a positive resolution for Dr. Reddy's.

Consequently, the USFDA has officially closed the inspection under 21 CFR 20.64(d)(3). This closure is a significant development for Dr. Reddy's, bringing certainty regarding the regulatory status of the facility and its products. The announcement was made by K Randhir Singh, company secretary, compliance officer & head-CSR.