FDA issues Form 483 to Aurobindo subsidiary following Raleigh facility inspection

The U.S. Food and Drug Administration has issued a Form 483 with 11 observations following an inspection of Aurolife Pharma’s manufacturing plant in Raleigh, North Carolina.

The inspection took place between March 24 and April 10, 2025, and focused on the facility’s production of inhalers and dermatological products.

Aurolife Pharma is a wholly-owned subsidiary of Aurobindo Pharma, one of India’s largest generic drug manufacturers. The company operates globally with a diverse product portfolio spanning antibiotics, antivirals, and treatments for chronic conditions. Its Raleigh plant is one of its key U.S.-based manufacturing sites supporting the company’s presence in regulated markets.

The Form 483 includes procedural observations, indicating issues identified during the inspection that may relate to quality systems or documentation practices. Aurobindo has confirmed that it will respond to the FDA within the required timeline and implement corrective and preventive actions as necessary.

According to the company, the findings are not expected to have a material impact on its ongoing operations or product supply from the site. Aurobindo noted that it remains committed to regulatory compliance and will provide updates if further developments occur.

However, this is not the first time in recent years that the company’s manufacturing operations have been cited by the FDA. In 2022, the agency issued a warning letter to Aurobindo regarding violations of current Good Manufacturing Practice (cGMP) for active pharmaceutical ingredients at a plant in Telangana, India. That warning letter came on the heels of an August 2021 site inspection that resulted in the agency issuing a Form 483.