US FDA conducts inspection at Rubicon Research’s Satara facility

The United States Food and Drug Administration (US FDA) conducted an unannounced inspection of Rubicon Research Limited's manufacturing facility located at J4/2, Additional MIDC, Satara - 415 004, Maharashtra, India from Monday, 5 October 2026 to Friday, 9 October 2026.

Upon conclusion of the current inspection, a Form 483 containing 1 observation was issued to the company. The observation is procedural in nature and does not relate to data integrity. The company is confident of working closely with the regulator to successfully conclude the evaluation in a timely manner.

A successful inspection outcome for the Satara facility would be the first successful unannounced inspection for this site. The previous inspection in January 2023 was the first ever US FDA inspection for the site, for which the company was provided prior intimation.

Upon conclusion, this would be the third successful unannounced US FDA inspection for the company in FY2026-27, considering the inspections of our Toronto (Canada) R&D facility in April 2026 and Pithampur (India) manufacturing facility in July 2026.

Additionally, our recently acquired manufacturing facility in East Brunswick, New Jersey, USA was inspected by the US FDA in May 2026, just prior to our acquisition of that facility in July 2026.