Dr Reddy's Srikakulam unit classified as voluntary action indicated by USFDA

Drugmaker Dr Reddy's Laboratories Ltd on Tuesday said it has received establishment inspection report from the US health regulator for its formulations manufacturing facility at Srikakulam in Andhra Pradesh, classifying the facility as voluntary action indicated.

The US Food & Drug Administration ( USFDA) had conducted a GMP and a Pre-Approval Inspection (PAI) conducted by at the company's formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh, India, intimated to the exchanges on July 18, 2025, Dr Reddy's Laboratories Ltd said in a regulatory filing.

"We wish to inform you that the company has received the Establishment Inspection Report (EIR) on October 20, 2025. The USFDA has classified the inspection outcome as 'Voluntary Action Indicated (VAI)'," it said, adding the inspection is officially closed.

Under voluntary action indicated (VAI), while objectionable conditions were found and documented during an inspection, the agency is not prepared to take or recommend regulatory action, as per the USFDA.