Dr. Reddy’s Laboratories has announced the conclusion of a USFDA inspection at its formulations manufacturing facility in Srikakulam, Andhra Pradesh. The inspection, related to a Pre-Approval Inspection (PAI), has been classified as Voluntary Action Indicated (VAI). This indicates the USFDA will not take further action at this time, and the inspection is officially closed as of October 20, 2025. The company views this as a positive step in maintaining compliance.
USFDA Inspection Update
Dr. Reddy’s Laboratories has received the Establishment Inspection Report (EIR) following a USFDA inspection conducted at their formulations manufacturing facility FTO 11 in Srikakulam, Andhra Pradesh, India.
Voluntary Action Indicated (VAI)
The USFDA has classified the inspection outcome as ‘Voluntary Action Indicated (VAI)’ on October 20, 2025. This classification signifies that the USFDA will not be taking further regulatory action at this time. The inspection is now officially closed. The initial intimation regarding the GMP and Pre-Approval Inspection (PAI) was dated July 18, 2025.
Source: BSE
