Medtronic Spine received a Form 483 for various process control deviations at the conclusion of a Nov. 28, 2011, – Dec. 5, 2011, inspection at its Sunnyvale, Calif., plant.
Thermometers used in a storage room for bone cements that needed to be kept cold were past due for calibration, the form states. Warehouse staff told FDA inspectors the thermometers were meant to be replaced before the inspection, it adds.
In addition, adhesive used to bind bone tamp components during the assembly process had an expiration date noted on the packaging, but there was no reference to checking the expiration date within the lot history record. That means the process control procedures necessary to ensure conformance to specification were not adequately established, the Form 483 states.
Finally, certain corrective and preventive action (CAPA) procedures failed to include any way to verify the effectiveness of completed actions. For example, one CAPA report stated no verification of effectiveness was needed, even though the action involved changes to instructions and material handling.
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