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

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

The company will submit a comprehensive response to the USFDA within the stipulated timeline, addressing each observation with appropriate corrective and preventive actions. The company is committed to maintaining the highest standards of quality and compliance across all its operations.

The company does not expect this development to have any material impact on the current business operations or existing supplies from this facility.