USFDA issues Form 483 with 11 observations to Raleigh plant of Aurobindo Pharma arm
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Synopsis
Aurobindo Pharma Ltd announced that the USFDA issued a Form 483 with 11 observations following an inspection of its Aurolife Pharma LLC's Raleigh plant in North Carolina. The company stated that the observations are procedural and it will respond with corrective actions. Aurobindo Pharma anticipates no significant impact on its operations or supplies from the facility.
By PTI
Last Updated:
Aurobindo Pharma Ltd on Friday said the US health regulator has issued a Form 483 with 11 observations to the Raleigh plant at North Carolina, USA, owned by its arm, Aurolife Pharma LLC. The US Food and Drug Administration (USFDA) had conducted inspection at the plant from March 24, 2025, to April 10, 2025, Aurobindo Pharma said in a regulatory filing.
The company further said, "We will submit a comprehensive response to the USFDA within the stipulated timeline, addressing each observation with appropriate corrective and preventive actions."
Asserting that it is committed to maintaining the highest standards of quality and compliance across all its operations, Aurobindo Pharma said, "We do not expect this development to have any material impact on the current business operations or existing supplies from this facility."
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"At the conclusion, the USFDA issued a Form 483 with 11 observations. These observations are procedural in nature," it added. The company further said, "We will submit a comprehensive response to the USFDA within the stipulated timeline, addressing each observation with appropriate corrective and preventive actions."
Asserting that it is committed to maintaining the highest standards of quality and compliance across all its operations, Aurobindo Pharma said, "We do not expect this development to have any material impact on the current business operations or existing supplies from this facility."
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