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Aurobindo Pharma's US Plant Gets 11 FDA Observations

  • 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.

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