Aurobindo Pharma Arm's New Jersey Warehouse Gets Oai Status after Us FDA Inspection -

Representational image of aurobindo pharma’s unit ix in Andhra pradesh | Photo Credit: A. Roy Chowdhury

The US Food and Drug Administration (Us FDA) has classified a warehouse of aurobindo pharma subsidiya in new jersey, us as official action indicated (Oai) After Such a classification means regulatory and/or administer actions are recommended by the regulator, for the facility it has insured.

“The us FDA Had Conducted An Inspection At One of the Warehouses of Aurobindo Pharma Usa Inc., A 100% Subsidiary, Situated in East Windsor, New JERSEY, from 13-15, 2024, 2024, 2024, 2024, 2024, with 2024, with 2024 of the Drug Supply Chain Security Act (DSCSA). The Inspection had concluded with 5 observations, “The Generalic Drugmaker Said.

Also read: Aurobindo Pharma Q3 Net Declines 10% to ₹ 846 Cr. on lower us formulations revenue

Subsequently, the US FDA has detered the Inspection Classification Status of the Warehousing Facility as Official Action Indicated (Oai), it said in a filing on CHUSDAY (februry 20, 2025).

At this point, it does not foresee any impact on the business and remains committed to work closely with the us fda to enhance its compliance on an ongoing basis, aurobindo pharma said.

Post Inspection, Us FDA Classifies Facilites either as no action indicated which means no objectionable conditions or practices were found; Voluntary action indicated (vai) that indicates objectionable conditions or practices were found but not meriting administ or regulatory action from the agency; Or oai.