Medtronic Unit Gets Form 483 for Process Control Issues

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.
The GMP Letter