Aurobindo Pharma announced that the United States Food and Drug Administration (US FDA) has completed its inspection at Unit II of Apitoria Pharma Private Limited, a wholly-owned subsidiary of Aurobindo, located in Telangana. The inspection, which was conducted from September 23 to 27, 2024, concluded with 10 observations from the US FDA.
Inspection Findings
The 10 observations raised by the US FDA are procedural in nature. Aurobindo Pharma stated that these will be addressed within the stipulated response time as per regulatory requirements. The company noted that the inspection was completed on September 27, 2024, at 8:00 PM.
Delay in Notification
The delay in notifying the stock exchanges was attributed to the unavailability of senior technical staff, who were required to review the nature of the observations before making a public disclosure.
Company’s Next Steps
Aurobindo Pharma is expected to respond to the US FDA’s observations, aiming to address any concerns raised during the inspection. Further updates will be provided to the stock exchanges if any new developments arise.
The outcome of this inspection and the company’s subsequent actions could have implications for Aurobindo Pharma’s operations and compliance status in the U.S. market.
