News about "Official Action Indicated "

US FDA Places Sun Pharma's Baska Facility Under 'Official Action Indicated' After Inspection

US FDA Places Sun Pharma's Baska Facility Under 'Official Action Indicated' After Inspection

Sun Pharmaceutical Industries Ltd said the U.S. Food and Drug Administration (FDA) has assigned an “Official Action Indicated” (OAI) status to its Baska manufacturing facility following a recent regulatory inspection.

Official Action Indicated | 18/12/2025 | By Darshana

US FDA Classifies Lupin's Pithampur Unit-2 as Official Action Indicated

US FDA Classifies Lupin's Pithampur Unit-2 as Official Action Indicated

The US Food and Drug Administration (FDA) has concluded its inspection of Lupin’s Pithampur Unit-2 manufacturing facility, issuing a Form 483 with four observations.

Official Action Indicated | 04/10/2025 | By Dineshwori 419

Torrent Pharmaceuticals Receives EIR from USFDA for Dahej Facility

Torrent Pharmaceuticals Receives EIR from USFDA for Dahej Facility

The Dahej facility was placed under OAI by the USFDA based on the March 2019 Inspection outcome.

Official Action Indicated | 25/08/2023 | By Manvi 1364


 

 

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