A-VOX Systems Inc.

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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