logo
  

FDA Issues Warning Letter To Medtronic's Diabetes Business

American-Irish registered medical devices company- Medtronic Plc (MDT), said on Wednesday that it received a warning letter from the U.S. Food and Drug Administration or FDA on the inadequacy of?specific medical device quality system requirements at the Northridge facility, the headquarters of its Diabetes Business.

The notice from the federal agency focuses on the devices related to the areas of risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events at Northridge plant.

In a bid to ensure the safety at the site, the Dublin-headquartered firm said it will apply resources from across the company and utilize external experts.

The company added it is also "implementing a range of corrective actions and process improvements related to the observations, and will continue reviewing these actions with the FDA."

FDA had issued a warning on December 9, following an inspection that concluded in July. The inspection was related to recalls of the MiniMed 600 series insulin infusion pump, and a remote controller device for MiniMed 508 and Paradigm pumps.

For comments and feedback contact: editorial@rttnews.com

Business News

Follow RTT