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CRS Form 483 Cites Design Failures

January 29, 2010
CRS Medical Diagnostics has received a Form 483 with several design control-related observations, including failure to identify design outputs essential for proper device function. The New Berlin, Wis., facility did not validate its design using production units under actual or simulated-use conditions, the Sept. 24 to Oct. 1 inspection found.
The GMP Letter