Aurobindo has reported to the National Stock Exchange of India that the FDA issued a Form 483 on April 11, 2025, one day after the agency completed an inspection of a manufacturing facility in North Carolina, USA. According to the company, the Form 483, which has not yet been published by the FDA, includes 11 observations that “are procedural in nature.” The Raleigh facility is owned by a subsidiary, Aurolife Pharma, and manufactures dermatologic products in addition to inhalers, the company noted.
Aurobindo wrote, “We will submit a comprehensive response to the USFDA within the stipulated timeline, addressing each observation with appropriate corrective and preventive actions. The Company is committed to maintaining the highest standards of quality and compliance across all its operations.”
Read the Aurobindo report
