FDA warns Prodigy Diabetes Care over glucose testing systems

Prodigy Diabetes Care got smacked with an FDA warning letter for a number of medical device reporting and quality system violations involving various blood glucose testing systems, monitoring systems and meters. Regulators criticized the company for not having processes in place to allow for timely reporting and handling of manufacturing problems or product complaints, among other issues. The FDA inspected the company's Charlotte, NC, facility from March 5, 2012 to April 16, 2012, and issued their warning letter on Feb. 22, before formally posting it online on July 23. Warning letter