Dr. Reddy’s Laboratories Srikakulam Facility Receives USFDA VAI Classification

Dr. Reddy’s Laboratories Ltd. informed exchanges that the United States Food & Drug Administration (USFDA) has closed the inspection of its formulations manufacturing facility in Srikakulam, Andhra Pradesh.

According to a regulatory filing, the company received the Establishment Inspection Report (EIR) on March 4. The USFDA classified the inspection outcome for the facility, identified as FTO-SEZ PU01, as ‘Voluntary Action Indicated’ (VAI). The regulator concluded that the inspection is officially closed under 21 CFR 20.64(d)(3).

This update follows a prior intimation in December 2025, regarding a Good Manufacturing Practice (GMP) assessment and a Pre-Approval Inspection (PAI) conducted by the US regulator at the site.