Utah Medical Upholds Product Safety, Questions FDA Inspector Credentials
This article was originally published in The Gray Sheet
Executive Summary
Utah Medical Products will challenge during pre-trial discovery whether FDA's inspectional observations of the Midvale, Utah facility can be construed as QSR violations
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Utah Medical Defends Its QSR Compliance, Prepares To Go To Trial
Utah Medical Products plans to argue in a federal lawsuit that FDA expects it to apply unwritten industry standards to its manufacturing processes
FDA v. Utah Medical
Aug. 30 trial date set for Salt Lake City federal court to hear Department of Justice's Aug. 9, 2004 complaint seeking to halt firm's sales after an FDA inspection cited persistent QSR deviations at Midvale, Utah facility dating to 2001 (1"The Gray Sheet" Aug. 16, 2004, p. 6)...