Strides Pharma’s Bengaluru facility gets EIR from US-FDA after successful inspection

After five observations from the global drug regulator, Strides subsequently submitted a comprehensive response addressing the observations along with corrective and preventive actions

Strides Pharma Science Limited has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA), marking the successful closure of the regulatory inspection at its flagship manufacturing facility in Bengaluru.

The USFDA conducted a current Good Manufacturing Practices (cGMP) inspection from May 12 to May 20, 2026, which concluded with a Form 483 containing five observations. 

Strides subsequently submitted a comprehensive response addressing the observations along with corrective and preventive actions.

Following its review, the USFDA classified the inspection outcome as Voluntary Action Indicated (VAI) and issued the EIR, formally concluding the inspection.

The Bengaluru facility manufactures a broad portfolio of pharmaceutical dosage forms, including tablets, capsules and oral liquids, for regulated and other international markets. It supports both Strides’ existing commercial products and future growth initiatives.

The successful closure strengthens Strides’ regulatory standing and reinforces its commitment to maintaining global quality and compliance standards across its manufacturing operations.