Aurobindo Pharma announced that the inspection of its wholly-owned subsidiary, APL Healthcare Limited’s Unit-IV, by the US FDA has been closed. The facility, located in Andhra Pradesh, received a ‘Form 483’ with 05 observations following the inspection between December 08 and December 17, 2025. The final Establishment Inspection Report (EIR) classifies the status as ‘Voluntary Action Indicated’ (VAI), signifying that the inspection is now officially concluded.
US FDA Inspection Concludes
Aurobindo Pharma Limited has provided an update regarding the inspection conducted by the United States Food and Drug Administration (US FDA) at its subsidiary, APL Healthcare Limited (Unit-IV). The inspection took place at the Palchur facility in Andhra Pradesh between December 08 to December 17, 2025.
Inspection Outcome and Status
Following the review, the US FDA had initially issued a ‘Form 483’ detailing 05 observations at the unit. However, the company has since received the final Establishment Inspection Report (EIR). The facility has been officially classified as ‘Voluntary Action Indicated’ (VAI). This classification means the inspection process for this unit is now officially “closed”.
This information is being disclosed to comply with regulatory requirements and update stakeholders on the operational status of the key manufacturing unit.
Source: BSE
