The GAO has a report on quality control of high risk devices (pacemakers for example) for US manufactured and foriegn made. The report also mentions dilemmas faced in drug manufacture from another report done last November on the issue of quality control for all drug manufacturing.
A simple adage to remember is that “the quality of a device made anywhere by anyone is not self-policing, especially when done globally”.
Since I am busy adding to the new site, I am not up to commenting much. It is worth reading however.