USFDA Closes Inspection of Dr Reddy's Srikakulam Facility with VAI Classification
New Delhi: Dr. Reddy's Laboratories has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA) for its formulations manufacturing facility in Srikakulam, Andhra Pradesh, confirming the closure of the inspection with a "Voluntary Action Indicated" (VAI) classification.
According to the company’s regulatory filing, the USFDA issued the EIR on March 4, 2026, following a Good Manufacturing Practices (GMP) and Pre-Approval Inspection (PAI) conducted earlier at the company’s formulations manufacturing facility FTO-SEZ PU01 located in Srikakulam, Andhra Pradesh.
The company had previously informed stock exchanges on December 12, 2025 about the inspection conducted by the US drug regulator at the facility. The latest communication confirms that the inspection has now been officially closed by the regulator.
The USFDA classified the inspection outcome as “Voluntary Action Indicated” (VAI), which means that while certain observations may have been noted during the inspection, they do not require regulatory or enforcement action by the agency.
With the issuance of the Establishment Inspection Report, the inspection process has been formally concluded in accordance with 21 CFR 20.64(d)(3), the regulatory provision governing the release of inspection reports.
Also Read: Dr Reddy's Labs gets 5 USFDA observations for Srikakulam facility
