The USFDA conducted a current Good Manufacturing Practices (cGMP) inspection from May 12 to May 20, 2026. The inspection concluded with a Form 483 containing five observations, as previously disclosed by the company. Strides said it submitted a comprehensive response addressing all five observations within the stipulated timeline.
Based on the company’s response and the corrective and preventive actions implemented, the USFDA classified the inspection outcome as Voluntary Action Indicated (VAI). The USFDA has subsequently issued the EIR, thereby concluding the inspection at the Bengaluru facility.
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What is a Form 483
A Form 483 is a list of observations made during the inspection and is issued by the USFDA inspectors post the completion of the inspection. The inspector will communicate and explain these observations to the supplier during the closing conference. But a Form 483 does not represent a final FDA determination regarding the facility’s GMP compliance.
Post Form 483 is issued, the company is given 15 days to submit its response to the USFDA explaining what steps the company will take to resolve the observations made by the USFDA.
Establishment Inspection Report (EIR)
Based on the inspection and the response given by the company to the USFDA, the FDA will release an Establishment Inspection Report (EIR) within 30 days of the inspection.
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The EIR reflects the FDA’s official determination of a factory’s GMP compliance. FDA and the Inspection Classification Database classify the inspection by each project area with one of three classifications. The three classifications displayed are:
No Action Indicated (NAI): Given if no violations were observed. The facility can continue selling approved drugs and will also receive approvals of new filings.
Voluntary Action Indicated (VAI): Given when violations are found, but the problems do not justify further regulatory action. Improving GMP compliance is voluntary in this case. The facility can continue selling approved drugs and will also receive approvals of new filings.
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Official Action Indicated (OAI): Given if violations found on-site require further administrative sanctions and mandatory corrective actions.
Shares of Strides Pharma Science Ltd ended at ₹955.00, up by ₹9.40, or 0.99%, on the BSE.
