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USFDA clears Strides' Bengaluru plant after Form 483
Strides' flagship Bengaluru plant received USFDA's EIR after a five-observation Form 483; the VAI classification formally closes the cGMP inspection cycle.
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Strides Pharma Science said Thursday that the U.S. Food and Drug Administration closed its inspection of the company's flagship manufacturing plant in Bengaluru, issuing an Establishment Inspection Report (EIR) that records the outcome as Voluntary Action Indicated.
Inspectors were at the plant from May 12 to May 20, 2026 for a current Good Manufacturing Practices (cGMP) check. The visit ended with a Form 483 that listed five observations. Strides said it submitted a response within the stipulated timeline and implemented corrective and preventive actions, or CAPAs, to address the points raised. The FDA then classified the inspection as VAI and issued the EIR, formally concluding the process.
VAI is the middle tier of the agency's three-step inspection grading. The FDA uses it when inspectors found issues and the company's response was adequate; the agency then has no further action planned. The outcome is one step below No Action Indicated, the cleanest grade, and one step above Official Action Indicated, which can lead to warning letters or more severe consequences. The EIR puts the classification on the official record for the site.