USFDA issues Form 483 with 11 observations to Raleigh plant of Aurobindo Pharma arm

New Delhi: 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.

"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."