RUBICON : USFDA ISSUES FORM 483 WITH 5 OBSERVATIONS AT AMBERNATH PLANT

• Unannounced inspection of the Ambernath, Maharashtra manufacturing facility from 21 to 29 October 2026, triggered by a product filing • Comprehensive GMP inspection plus product application under review; Form 483 carries 3 observations on system improvement and 2 on product application • All 5 observations are stated to be procedural in nature and do not relate to data integrity • Company says it is confident of working closely with the regulator to conclude the evaluation in a timely manner • Thane and Canada R&D sites had zero observations with EIR received; New Jersey facility got EIR with VAI status; Pithampur (2 observations) EIR awaited, Satara got 1 observation in Oct-26

Rubicon Research Ltd

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