The U.S. FDA inspected Unit-IV of APL Healthcare in SPSR Nellore District, Andhra Pradesh, from December 8 to 17 and issued a Form 483 with five observations.
| Photo Credit: Reuters

Representational image of Aurobindo Pharma’s Unit IX in Andhra Pradesh
| Photo Credit: A. Roy Chowdhury

The U.S. Food and Drug Administration (U.S. FDA) has classified a warehouse of Aurobindo Pharma subsidiary in New Jersey, U.S. as Official Action Indicated (OAI) after an inspection it conducted. Such a classification means regulatory and/or administrative actions are recommended by the regulator, for the facility it has inspected.

“The U.S. 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 May 13-15, 2024, with regards to compliance of the Drug Supply Chain Security Act (DSCSA). The inspection had concluded with 5 observations,” the generic drugmaker said.

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Subsequently, the U.S. FDA has determined the inspection classification status of the warehousing facility as Official Action Indicated (OAI), it said in a filing on Thursday (February 20, 2025).

At this point, it does not foresee any impact on the business and remains committed to work closely with the U.S. FDA to enhance its compliance on an ongoing basis, Aurobindo Pharma said.

Post inspection, U.S. FDA classifies facilities 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 administrative or regulatory action from the agency; or OAI.

Aurobindo Pharma shares were 1.17% lower at ₹1,123 apiece on the BSE around 10.30 a.m.