Strides Pharma Science receives 5 USFDA observations after Bengaluru facility inspection

Drug firm Strides Pharma Science Ltd on Wednesday (May 20) said the United States Food and Drug Administration (USFDA) has completed a routine current Good Manufacturing Practices (cGMP) inspection at the company’s flagship facility in Bengaluru.The inspection was conducted from May 12, 2026, to May 20, 2026. At the conclusion of the inspection, the USFDA issued a Form 483 with five observations, the company said in an exchange filing on Wednesday.

Strides Pharma said it will respond to the observations within the stipulated timeline prescribed by the regulator. The company added that it will keep the stock exchanges informed of any further developments related to the matter.
Also Read: Strides Pharma maintains up to $400 million FY28 target for North America, sees US recovery from H2FY27What is a Form 483A Form 483 is a list of observations made during the inspection and is issued by the USFDA inspectors after 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.

Shares of Strides Pharma Science Ltd ended at ₹1,145.00, down by ₹8.65, or 0.75%, on the BSE.

Also Read: Strides Pharma Q4 Results: Operational strength lifts profit despite softer margins