FDA Broke Law During Plant Inspections, News Service Says

FDA Broke Law During Plant Inspections, News Service Says

CAMP HILL, Pa., Feb. 4 /PRNewswire/ -- Budget reductions may have caused FDA to break a law governing the way it conducts factory inspections, jeopardizing an agency court case against a medical device company, according to the Dickinson's FDA Webview Internet news service (http://www.fdaweb.com/). FDA sued the company last fall for alleged manufacturing violations covering four years.

The law requires that FDA inspectors apply their independent judgment when writing up their observations in a plant, but in this case, FDA headquarters "massaged" how two inspectors wrote up alleged violations so the agency could sue Utah Medical Products in Midvale, Utah, according to pre-trial documents obtained by FDA Webview. The company says it made no violative products and there have been no health consequences attributable to conditions in its facility.

FDA Webview says that two decades of budget cutbacks have hamstrung FDA field operations and redirected resources to product approvals instead. The cuts have eliminated inspectors' training programs to the point where illegal headquarters direction may have begun to fill inspectors' knowledge gaps during complex plant inspections, the news service says.

Utah Medical Products filed a counterclaim February 1 against FDA, alleging the directed inspections were "tainted" by this practice.

Publishing daily on-line FDA regulatory news since 1999, FDA Webview with its 20,000-story archive is the leading source for FDA compliance and enforcement information. To request a free trial, visit: http://www.fdaweb.com/default.php?ea=trial.


Source: Dickinson's FDA Webview

CONTACT: David McFarland of Ferdic, +1-717-731-1426, for Dickinson's FDA
Webview

Web site: http://www.fdaweb.com/


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