Strides Pharma’s Bengaluru Facility Clears USFDA Inspection with VAI Classification
Strides Pharma Science Ltd has received the Establishment Inspection Report (EIR) from the USFDA for its Bengaluru manufacturing facility, formally closing the cGMP inspection conducted from May 12 to May 20, 2026. The inspection had resulted in a Form 483 containing five observations, to which the company submitted a detailed response within the stipulated 15-day period, along with corrective and preventive actions.
Following its review, the USFDA classified the inspection outcome as Voluntary Action Indicated (VAI) and subsequently issued the EIR, concluding the inspection process. A Form 483 represents observations identified by FDA inspectors and is not, by itself, a final determination of GMP compliance. The EIR reflects the regulator’s assessment following the inspection and the company’s response, with inspections generally classified as No Action Indicated (NAI), Voluntary Action Indicated (VAI), or Official Action Indicated (OAI).
Under NAI, no violations are identified; VAI indicates that observations exist but do not warrant further regulatory action, while OAI applies when violations require formal administrative sanctions and mandatory corrective measures. For Strides Pharma, the VAI classification means the identified issues did not lead to further regulatory action, while the closure of the inspection provides greater clarity on the facility’s regulatory status.