News about "Official Action Indicated "

US FDA Classifies Aurobindo Pharma's Eugia Unit-III Inspection as Official Action Indicated

US FDA Classifies Aurobindo Pharma's Eugia Unit-III Inspection as Official Action Indicated

Aurobindo Pharma said the US FDA has classified its inspection of Eugia Unit-III in Telangana as Official Action Indicated, while reaffirming its commitment to maintaining global quality manufacturing standards.

Official Action Indicated | 16/06/2026 | By News Bureau 108

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 327

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 616

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 1681


 

 

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