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Utah Medical’s 483

This article was originally published in The Gray Sheet

Executive Summary

Response to FDA quality system inspection observations (form FDA-483) addresses an alleged lack of injection molding and extrusion operation validation, the firm says. The Salt Lake City firm, which has pending lawsuits against FDA seeking access to export certificates that have been denied due to alleged QS/GMP non-compliance dating to 2001, asserts it "has been and is in compliance with a reasonable interpretation" of FDA quality system regulations (1"The Gray Sheet" March 1, 2004, p. 14). The Feb. 2 through March 3 inspection report does not cite a lack of sterilization validation or failure to follow MDR report procedures, as was alleged after a 2003 inspection, the firm claims. "There were no current observations to suggest or support concern" about device safety or effectiveness, Utah says...

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