USFDA issues Form 483 with three observations to Strides Pharma's Alathur facility

The regulatory body carried out a routine current Good Manufacturing Practices inspection at the company's formulations facility located in Alathur, Chennai

Strides Pharma Science Limited has announced regarding a United States Food and Drug Administration (USFDA) inspection at its manufacturing operations.

The regulatory body carried out a routine current Good Manufacturing Practices (cGMP) inspection at the company's formulations facility located in Alathur, Chennai. The inspection spanned ten days, commencing on September 2, 2026, and concluding on September 11, 2026.

Upon completion of the audit, the USFDA issued a Form 483 containing three observations. Strides Pharma Science Limited stated that it will submit its formal response addressing these observations to the USFDA within the stipulated timeframe.