Inspection Procedure Brings 483 for Everest Spine

Everest Spine’s receiving inspection procedure lacks a description of the visual and cosmetic inspections or functional test procedures performed prior to product release, according to an FDA Form 483.

The McLean, Va., company’s procedure only had a description of the records that must come with the devices when they are received from the contract manufacturer, the FDA said following an Aug. 19 to Aug. 20 inspection.

Additionally, Everest’s device history records lack documentation of the finished product testing and release of each lot of devices, and there is no record of the primary identification label used with each lot.

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