FDA 483 - Dental Prosthetic Services Inc - April 20, 2023

An FDA inspection of Dental Prosthetic Services Inc in Cedar Rapids, IA, a medical device manufacturer, revealed two significant observations. The firm failed to adequately maintain its device master record by not including UDI/UPC labeling specifications for Class II medical devices. Additionally, the device history record did not include or refer to the location of unique device identifiers or universal product codes for their Class II Anti-Snoring device.