Aurobindo Pharma Gets 11 FDA Observations After US Plant Inspection

15 Apr 2025 , 12:29 PM

Indian drug maker Aurobindo Pharma Ltd said U.S. Food and Drug Administration (US FDA) has completed an inspection of its wholly-owned step-down subsidiary Aurolife Pharma LLC, based in Raleigh, North Carolina.

The facility’s manufacture of inhalers and dermatological products were in scope during the inspection, which took place over an 18-day period from March 24, 2025, through April 10, 2025.

Following the audit, the US FDA issued a Form 483 with 11 observations at closure, which Aurobindo Pharma described as small procedural observations. In its assurance, the firm stated that it is preparing a fulsome response, including CAPA (corrective and preventive action) plan for each observation. This will be filed with the US FDA in the timeframe allowed.

Aurobindo Pharma reiterated their commitment towards adhering to the highest standards of quality and regulatory practice in all manufacturing operations, including US.

In the statement, the company also gave the reassurance that none of the observations would have any material impact on the operation of its business or the ongoing supply of product from the Raleigh facility. The drugmaker also said it would continue to inform the stock exchanges and stakeholders of any material developments in the case.

Aurobindo’s pro-active regulatory approach and its efforts to resolve the compliance issues, expeditiously and in accordance with law, reflects this development. The market participants and investors are likely to keep a close watch over the developments around the FDA’s subsequent action on the company’s CAPA submission.