Strides Pharma Science announced the completion of a routine USFDA inspection at its Alathur, Chennai formulations facility. The inspection, conducted between September 2, 2026, and September 11, 2026, resulted in the issuance of a Form 483 with three observations. The company stated it will respond to these observations within the stipulated time, assuring continued compliance and market access.
USFDA Inspection Concludes at Alathur Facility
Strides Pharma Science Limited has notified stakeholders regarding the conclusion of a routine inspection conducted by the United States Food and Drug Administration (USFDA). The inspection focused on current Good Manufacturing Practices (cGMP) at the company’s formulations facility located in Alathur, Chennai.
Inspection Period and Findings
The USFDA inspection took place during the period from September 2, 2026, to September 11, 2026. Upon completion of the inspection process, the USFDA issued a Form 483, detailing three observations. These observations are typically related to potential compliance issues identified during the on-site review.
Company’s Response and Future Steps
Strides Pharma Science has committed to addressing the observations. The company will submit its response to the USFDA within the regulatory timeframe. The company assures that it will continue to keep the stock exchanges informed should there be any further significant updates regarding this matter.
Source: BSE
