09-Oct-2026 20:17:01

RUBICONAcquisition and merger

RUBICON : US FDA ISSUES FORM 483 WITH 1 OBSERVATION FOR SATARA SITE

• US FDA conducted an unannounced inspection of the company's Satara, Maharashtra manufacturing facility from 5 October to 9 October 2026 • Form 483 containing 1 observation issued; observation is procedural in nature and does not relate to data integrity • Company said it is confident of working closely with the regulator to conclude the evaluation in a timely manner • A successful outcome would be the first successful unannounced inspection for the Satara site; the January 2023 inspection was the site's first-ever US FDA inspection and was with prior intimation • Upon conclusion, this would be the third successful unannounced US FDA inspection for the company in FY2026-27, after Toronto (Canada) R&D in April 2026 and Pithampur (India) in July 2026 • Recently acquired East Brunswick, New Jersey facility was inspected by the US FDA in May 2026, prior to its acquisition in July 2026

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