A formulation manufacturing facility of Aurobindo Pharma subsidiary Eugia Pharma Specialities in Rajasthan has been issued nine observations by the U.S. Food and Drug Administration.
The U.S. FDA inspection of the facility, Unit-II in Bhiwadi, Alwar, from November 3-14 concluded with nine observations. They are procedural in nature and will be responded to within the stipulated time. The development will not have any impact on existing operations of the unit, the parent company said in a filing on Friday.
VAI issued to API unit
In another filing, Aurobindo Pharma said the active pharmaceutical ingredient manufacturing facility (Unit I) of subsidiary Apitoria Pharma in Sangareddy district of Telangana has received an establishment inspection report from the U.S. FDA classifying the facility as Voluntary Action Indicated (VAI).
The regulator concluded the inspection as closed, the company said, citing that the U.S. FDA had issued a warning letter to the facility in January 2022 and followed it up with a for-cause inspection from August 21-29, 2025. On completion of the inspection, it had issued Form 483 with 5 observations.
The US FDA has since completed evaluation of the corrective actions. It has determined the issues cited in the warning letter and Form 483 have been adequately addressed. The unit has now received EIR classifying the facility as VAI.
Aurobindo Pharma shares closed 1.08% higher on Friday at ₹1,221.90 each on the BSE.
VAI is one of the three classifications the U.S. FDA issues to determine outcome of its inspection. VAI means objectionable conditions or practices were found, but the regulator is not prepared to take or recommend any administrative or regulatory action. No action indicated (NAI) is another classification to convey that no objectionable conditions or practices were found during the inspection. The third classification category is official action indicated or OAI that means regulatory and/or administrative actions are recommended.
Published – November 14, 2025 10:08 pm IST
