FDA Halts Sales at Medical Device Company - Jan 15, 2007

GE OEC Medical Systems signed a consent decree with FDA which prohibits the manufacturing and distribution of specified GE OEC Medical Systems X-ray surgical imaging systems at facilities in Salt Lake City, UT, and Lawrence, MA.

This action follows a Warning Letter issued to the company in March 2005. Here's one excerpt from the Warning Letter.

"Our inspection disclosed that your firm discovered that test technicians were not completing original test procedure documentation (Process History Records), but instead were copying test results from one device to another for a period of at least one year."

"Not only were test technicians found to be using photocopied device test results as noted above, but supervisory staff and management who reviewed and signed off on these records never caught this practice which occurred for at least one year."

Read the entire Warning Letter, FDA's Press Release announcing the Consent Decree, and a newspaper account of this action. Go to:
http://www.gmptrainingsystems.com/asp/resources.asp
Click on Timely Resource Articles.

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