Merge, Commed Hit With FDA Warnings Over Facility Violations

Law360, New York (September 4, 2012, 5:09 PM EDT) -- The U.S. Food and Drug Administration announced Tuesday it had issued separate warnings to medical device makers Merge Healthcare Inc. and Commed Inc. over issues uncovered during inspections of their respective facilities in Tennessee and Washington.

The FDA letters warned of adulteration at the Winchester, Tenn., facility where Merge produces blood pressure monitoring computer kiosks, while Washington-based Commed was cited for violations in its manufacturing of tracheostoma covers and stoma screens.

“Failure to promptly correct these violations may result in regulatory action being initiated by the...
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