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Medical Devices / Inspections and Audits

FDA Cites CME America Over Procedures for Controlling Nonconforming Products

Dec. 6, 2017

Out of 11 device history records at CME America’s facility in Golden, Colorado, seven lacked documentation that should have identified existing nonconformities, an FDA inspection revealed.

The agency issued a Form 483 following the inspection conducted from mid-July to early August noting the firm’s procedures for controlling the nonconforming products were inadequate.

CME America had also failed to include revisions made to its manufacturing operations in its device master record for the BodyGuard 323 Infusion Pump, and to provide documentation as evidence that validation activities had been conducted on its molding machines.

In a repeat observation, the agency cited the firm’s procedure for evaluating potential suppliers.

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