Strides Pharma Science Limited has received the Establishment Inspection Report (EIR) from the USFDA for its flagship manufacturing facility in Bengaluru, India. The inspection, conducted from May 12 to May 20, 2026, concluded with a Voluntary Action Indicated (VAI) classification. This closure signifies the successful resolution of the five observations previously noted and reinforces the company’s commitment to high-quality pharmaceutical manufacturing.
USFDA Inspection Successfully Concluded
Strides Pharma Science Limited (Strides) announced today that its flagship manufacturing facility located in Bengaluru, India, has successfully passed its recent inspection by the United States Food and Drug Administration (USFDA). The company received the Establishment Inspection Report (EIR), marking the official closure of the inspection process.
Inspection Details and Outcome
The USFDA conducted a Current Good Manufacturing Practices (cGMP) inspection at the Bengaluru facility from May 12 to May 20, 2026. While the inspection initially resulted in a Form 483 with five observations, Strides submitted a comprehensive response addressing all points within the stipulated timeline. Following the review of the company’s corrective and preventive actions, the USFDA has classified the inspection outcome as Voluntary Action Indicated (VAI).
Facility Significance and Future Outlook
This flagship facility is crucial for Strides, serving both regulated and other international markets. It manufactures a wide array of pharmaceutical dosage forms, including tablets, capsules, and oral liquids, supporting existing commercial products and future growth. The successful closure of this USFDA inspection strengthens Strides’ regulatory track record and reaffirms its dedication to delivering high-quality pharmaceutical products globally.
Source: BSE
