Aurobindo Pharma's US facility receives FDA Form 483
Aurobindo Pharma Limited announced the completion of a US Food and Drug Administration (USFDA) inspection at its Raleigh, North Carolina facility, owned by its step-down subsidiary, Aurolife Pharma LLC. The inspection, which took place from March 24, 2025, to April 10, 2025, concluded with the issuance of a Form 483 containing 11 observations, which Aurobindo Pharma characterized as procedural in nature. The facility is focused on manufacturing inhalers and derma products. Aurobindo Pharma has committed to providing a comprehensive response to the USFDA, including corrective and preventive actions, within the stipulated timeframe. The company does not anticipate the observations to have a material impact on current business operations or existing supplies from the plant.
This report was generated by FilingReader's AI system from regulatory filings and company disclosures. To request a correction, contact editorial@filingreader.com
News Alerts
Get instant email alerts when Aurobindo Pharma publishes news
Free account required • Unsubscribe anytime