USFDA classifies Aurobindo Pharma Inc's warehouse as OAI
Drug Approval

USFDA classifies Aurobindo Pharma Inc's warehouse as OAI

The USFDA has determined the inspection classification status of this warehousing facility as 'Official Action Indicated

  • By IPP Bureau | February 21, 2025

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 May 13, 2024 to May 15, 2024, with regards to compliance of the Drug Supply Chain Security Act (DSCSA). The inspection had concluded with 5 observations.

Subsequently, the USFDA 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.

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