Category: Device 483s
Inspection date range: 7/11/11-7/15/11
Company: Applied Diabetes Research, Inc.
1420 Valwood Pkwy
Carrollton, TX 75006-8386
Inspector(s): Lauren E. Skokan
Observations: An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of information that reasonably suggests that a marketed device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.