Poor Supplier Evaluations, Other Violations Lead to Form 483 for CME America

December 2, 2016

A Colorado device maker has 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 that potential suppliers were not evaluated and selected based on their ability to meet specified requirements. The company had criteria to purchase goods and services but lacked evidence that the criteria was met.

The company did not respond to a request for comment. 

The FDA expects you to hold your suppliers, vendors and contractors in a state of control. You are responsible if an inspection turns up problems with materials or services you have outsourced.  You need a supplier auditing program that helps you stay on top of all your outsourced operations. The FDAnews Brief Supplier Auditing: A Four-Part Plan helps you build a system that shows the FDA and other regulators that you hold the reins when it comes to supplier quality.

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