www.fdanews.com/articles/124086-crs-form-483-cites-design-failures
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
The GMP Letter