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India, USFDA

By Gurminder Mangat , 12 April 2025
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Aurobindo Pharma Faces FDA Scrutiny at U.S. Facility, Market Reacts with Caution

Aurobindo Pharma Ltd. has disclosed that the U.S. Food and Drug Administration (USFDA) issued a Form 483 with 11 procedural observations following a recent inspection of its North Carolina-based manufacturing unit, operated by its wholly owned subsidiary, Aurolife Pharma LLC. Conducted between March 24 and April 10, 2025, the inspection concluded with compliance concerns that, while non-critical, have prompted the company to implement corrective actions.

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