Home / Business and Economy / USFDA Clears Aurobindo Pharma Plant: VAI Status Achieved
USFDA Clears Aurobindo Pharma Plant: VAI Status Achieved
12 Mar
Summary
- USFDA inspection of Aurobindo's Nellore unit concluded with a satisfactory VAI classification.
- Voluntary Action Indicated (VAI) means no immediate regulatory action is planned by the USFDA.
- The inspection of APL Healthcare Ltd's Unit-IV was conducted from December 8-17, 2025.
On March 12, 2026, Aurobindo Pharma revealed it had received a favorable Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA). The report classified the manufacturing unit in Nellore, Andhra Pradesh, as Voluntary Action Indicated (VAI), signifying a satisfactory outcome.
A VAI classification by the USFDA indicates that while some objectionable conditions or practices were noted, the agency does not intend to pursue administrative or regulatory action at this time. This inspection covered Unit-IV of APL Healthcare Ltd, a wholly-owned subsidiary.
The USFDA conducted its inspection of the Nellore facility between December 8 and December 17, 2025. Following the inspection, a Form 483 was issued detailing five observations. The company has now received the EIR, officially closing this inspection.
