Aurobindo Pharma announced that its API manufacturing Unit 2, located in Gaddapotharam Village, Telangana, has been classified as “Voluntary Action Indicated” (VAI) by the US Food and Drug Administration (US FDA). The classification comes after an inspection conducted by the US FDA from September 23 to 27, 2024, followed by the issuance of an Establishment Inspection Report (EIR) on January 28, 2025.
The VAI classification signifies that the inspection is closed, and no further regulatory action is required. The inspection had earlier resulted in Form 483 with 10 procedural observations, which the company addressed to the regulatory authority’s satisfaction.
The company clarified that the regulatory action will have no impact on its financials or operations. This is a positive development for Aurobindo Pharma, as VAI classification indicates compliance improvements and reduced risk of penalties or production halts.
Background on Inspection:
- Inspection Dates: September 23-27, 2024
- Form 483 Observations: 10 procedural deviations related to cGMP standards
- Current Status: VAI classification indicates resolved issues
Aurobindo Pharma’s proactive engagement and prompt resolution of procedural matters underline its commitment to meeting global compliance standards. The company remains on track to sustain production and exports without disruptions.
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