Tag: Prodigy

CHARLOTTE, N.C. - Prodigy Diabetes Care has conducted a regulatory assessment by an independent auditor to examine, review and revise certain procedures and training to ensure compliance with FDA requirements, it told patients, caregivers and partners in a Sept. 4 letter.“Prodigy assures you that this attention to improvement is an ongoing effort to ensure full compliance,” stated CEO Richard Admani in the letter.In a Feb. 22 letter, the FDA warned Prodigy about numerous violations, including...

CHARLOTTE, N.C. - Add Prodigy Diabetes Care to the list of HME manufacturers that has received warning letters from the U.S. Food and Drug Administration (FDA).In a letter dated Feb. 22 but only posted to the agency's website July 11, the FDA faults Prodigy with, among other things, “failure to report to the FDA no later than 30 days after the day that your firm received or otherwise became aware of information that a device that it markets may have caused or contributed to a death or serious...