Aurobindo Pharma Faces USFDA Observations at Raleigh Plant

Aurobindo Pharma Ltd received a Form 483 from the USFDA with 11 procedural observations for its Raleigh plant managed by Aurolife Pharma LLC. The inspection occurred from March 24 to April 10, 2025. The company plans to address all issues promptly, asserting no significant impact on its operations.

Aurobindo Pharma Ltd, a key player in the pharmaceutical industry, disclosed on Friday that it has received a Form 483 from the US Food and Drug Administration (USFDA), noting 11 procedural observations at its Raleigh, North Carolina plant, operated by its subsidiary, Aurolife Pharma LLC.

The inspection by USFDA, which took place between March 24 and April 10, 2025, resulted in the issuance of the observations. Aurobindo Pharma has assured stakeholders that it will address each issue comprehensively within the stipulated timeline through appropriate corrective and preventive actions.

The company emphasized its commitment to quality and compliance, stating that this development is not expected to impact its current operations or existing supplies from the Raleigh facility.

(With inputs from agencies.)