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Medtronic Unit Gets Form 483 Because of Hold Procedures

December 9, 2010
Medtronic’s cardiac rhythm disease management division has received a Form 483 with several observations related to hold procedures. The Sept. 2 form notes products on hold were not contained or identified. Certain products were not labeled to identify their status or stored in a segregated containment area at the Mounds View, Minn., facility. Reasons for placing products on hold were not documented or clearly described. The company has responded to the FDA and is working with the agency to resolve outstanding issues, Medtronic spokesman Christopher Garland said.
The GMP Letter