Strides Pharma Bengaluru Plant Gets 5 USFDA Observations, VAI Classification
New Delhi: Strides Pharma Science Limited (Strides) has announced that its flagship manufacturing facility in Bengaluru, India, has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA), indicating the successful closure of the inspection conducted at the facility.
The USFDA conducted a current Good Manufacturing Practices (cGMP) inspection of the facility from May 12 to May 20, 2026. As previously disclosed to the stock exchanges on May 20, 2026, the inspection concluded with the issuance of a Form 483 that contained five observations.
The Company submitted a comprehensive response addressing all observations within the stipulated timeline. Based on the Company's response and the corrective and preventive actions implemented, the USFDA has classified the inspection outcome as Voluntary Action Indicated (VAI) and has issued the Establishment Inspection Report (EIR), thereby concluding the inspection.
The facility is Strides' flagship manufacturing site and serves regulated and other international markets. The facility manufactures a broad portfolio of pharmaceutical dosage forms, including tablets, capsules and oral liquids, supporting both existing commercial products and future growth opportunities.
The successful closure of the inspection further strengthens Strides' regulatory track record and reinforces the Company's commitment to supplying high-quality pharmaceutical products to patients across global markets.
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