Company: A-VOX Systems Inc.Date: 4/18/2002 Product: Various oximeter models used for whole blood measurements and disposable cuvettes Failure to maintain procedures to ensure all purchased or otherwise received products and services conform to specified requirements [21 CFR 820.50; see also 820.80]. For example, your firm failed to ensure that the supplier of the main computer...Read More

Company: American Dental Technologies Inc.Date: 4/18/02 Product: Dental device systems, including PulseMaster 600-IQ and DioLase ST Dental Laser System, PowerPAC High Speed Curing Light System, KCP 5 and 1000 Air Abrasive Kinetic Cavity Preparation System and Ultracam Intraoral Camera System Failure to maintain adequate device master records [21 CFR 820.181] [FDA- 483 Item 5]. For...Read More