Aurobindo Pharma Gets 3 USFDA Observations for Apitoria Unit-V, Classified as VAI
New Delhi: Aurobindo Pharma Limited has announced that the United States Food and Drug Administration (USFDA) has classified Unit-V of its wholly owned subsidiary, Apitoria Pharma Private Limited, as "Voluntary Action Indicated" (VAI), marking the closure of its inspection.
The US FDA had conducted an inspection at the API manufacturing facility located in Pashamylaram, Telangana, from December 1 to December 12, 2025. At the conclusion of the inspection, the regulator had issued a Form 483 with three observations.
Following the review, the facility has now received an Establishment Inspection Report (EIR) from the US FDA, confirming the VAI classification and formally closing the inspection process.
The VAI status indicates that while certain observations were noted during the inspection, they are not severe enough to warrant regulatory enforcement action, provided appropriate corrective measures are taken.
The company disclosed that the facility inspected is involved in active pharmaceutical ingredient (API) manufacturing and is a key part of its operations.
According to the company filing, the development follows its earlier communication regarding the inspection and reflects regulatory closure of the matter.
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