A Colorado device maker received a Form 483 after investigators witnessed supplier observations and quality system issues. In total, six observations were listed.

Investigators observed that CME America’s procedures for design change were not adequately established and complaints involving the possible failure of a device were not reviewed, evaluated and investigated where necessary.

The inspection also pointed out those potential suppliers were not evaluated and selected based on their ability to meet specified requirements. The company has criteria to purchase goods and services, but lacked evidence that the criteria were met. — Jeff Kinney