FDA sends warning letter over alleged violations at leading device reprocessor Alliance Medical
This article was originally published in Clinica
Executive Summary
In the midst of discussions over the regulation of third-party medical device reprocessors, the US FDA has side-stepped its critics by issuing a highly publicised warning letter to industry leader Alliance Medical. The warning letter claimed that agency inspectors uncovered serious problems at the Phoenix, Arizona-based company's decontamination facility in Florida.