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USFDA Flags Aurobindo's Eugia Unit-II with OAI Status After Bhiwadi Inspection
Hyderabad: Aurobindo Pharma Limited has recently informed that the United States Food and Drug Administration (USFDA) has classified Unit-II of its wholly owned subsidiary, Eugia Pharma Specialities Limited, as "Official Action Indicated" (OAI) following a recent inspection.
The regulatory update comes after a US FDA inspection conducted at the company’s manufacturing facility located in the RIICO Industrial Area, Phase III, Bhiwadi, Rajasthan, between November 3 and November 14, 2025. At the conclusion of the inspection, the agency issued a Form 483 citing nine observations related to the facility.
Following a detailed review, the US FDA has now officially categorized the inspection outcome as OAI, indicating that regulatory or compliance-related actions may be warranted based on the findings.
Despite this classification, Aurobindo Pharma stated that it does not anticipate any immediate impact on its business operations. The company emphasized its continued commitment to upholding stringent quality standards across all its global manufacturing facilities.
The company has also assured stakeholders that it will provide further updates to stock exchanges if there are any significant developments related to this matter.
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