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(20 Feb 2025, 09:02)

USFDA inspects Aurobindo Pharma USA Inc.'s warehouse facility in New Jersey


Aurobindo Pharma announced that the United States Food and Drug Administration (US FDA) had conducted an inspection at one of the warehouses of Aurobindo Pharma USA Inc., (a 100% subsidiary of the Company), situated at East Windsor, New Jersey, from 13 May 2024 to 15 May 2024, with regards to compliance of the Drug Supply Chain Security Act (DSCSA). The inspection had concluded with 5 observations.

Subsequently, the US FDA has determined the inspection classification status of this warehousing facility as ‘Official Action Indicated (OAI)'.

At this point in time, the Company doesn't foresee any impact on the business.

The Company remains committed to work closely with the US FDA and continues to enhance its compliance on an ongoing basis.

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