Aurobindo Pharma's subsidiary, Aurolife Pharma LLC, received 11 observations from the US FDA following an inspection of its Raleigh plant in North Carolina.
The inspection took place from March 24 to April 10, 2025.
Aurobindo Pharma will provide a detailed response to the FDA within the required timeline, addressing each observation with appropriate corrective and preventive measures.
The company stated that it does not expect this development to have any material impact on current business operations or existing supplies from the facility.