USFDA17 Aug 2026, 07:37 am
Aurobindo Pharma subsidiary's US FDA inspection classified VAI
AI Summary
Aurobindo Pharma Ltd announced that its wholly-owned step-down subsidiary, Aurolife Pharma LLC, has received an Establishment Inspection Report (EIR) from the USFDA for its Raleigh Plant in North Carolina. The inspection, conducted from March 24 to April 10, 2025, resulted in 11 observations but has been classified as Voluntary Action Indicated (VAI). This classification means the USFDA has closed the inspection and pending applications for multiple inhalers and other dosage forms manufactured at this facility can now proceed through the USFDA's review process.
Key Highlights
- USFDA inspection of Aurobindo's Raleigh plant classified as VAI.
- 11 observations were issued on Form 483.
- Inspection is now closed by the USFDA.
- Pending inhaler and dosage form applications can now progress.
Price Impact
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