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USFDA inspects Aurobindo Pharma's Raleigh Plant in North Carolina

Issues 11 observations under Form 483

Aurobindo Pharma announced that the United States Food and Drug Administration (USFDA) has conducted an inspection at Raleigh Plant, North Carolina, USA, owned by Aurolife Pharma LLC, a wholly owned step-down subsidiary of the Company, established for manufacturing Inhalers and Derma products, from 24 March 2025 to 10 April 2025.

The inspection was completed on 10 April 2025 and at the conclusion, the USFDA issued a Form 483 with 11 observations. These observations are procedural in nature.

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First Published: Apr 11 2025 | 3:22 PM IST

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