USFDA clears Strides’ manufacturing unit in Bengaluru
Strides Pharma Science Limited announced that its Bengaluru manufacturing facility received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA), successfully closing a regulatory inspection. The facility addressed five observations from the cGMP inspection, leading to a Voluntary Action Indicated (VAI) classification.
Why it matters
This clearance is crucial for Strides Pharma, ensuring its ability to continue manufacturing and supplying pharmaceutical products to regulated international markets, impacting drug availability and the company's financial health.
Strides Pharma Science Limited on Thursday said its flagship manufacturing facility in Bengaluru has received the Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (USFDA), marking the successful closure of the regulatory inspection.
The USFDA conducted a current Good Manufacturing Practices (cGMP) inspection of the facility between May 12 and May 20, 2026. The inspection concluded with the issuance of a Form 483, containing five observations.
Strides said it submitted a comprehensive response to the observations within the stipulated timeline and implemented corrective and preventive actions (CAPAs) to address the issues raised.
After assessing the company’s response and the actions taken, the USFDA classified the inspection outcome as Voluntary Action Indicated (VAI) and issued the EIR, thereby concluding the inspection.
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