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 board (i.e., _____ Main Board) documented all of the required test results to indicate the supplier’s quality acceptance of the _____ computer boards manufactured and delivered to your firm.

FDA District: Dallas District Office