Company: Cordis Corp.
Product: “Cypher Sirolimus-Eluting Coronary Stent”
Failure to adequately validate for its intended purpose and according to an established protocol computer software used as part of the production or quality system, and failure to document validation activities and results, as required by 21 CFR 820.70(i).
The automated _____ data acquisition system, used to ensure the integrity of the analytical data generated from laboratory chromatography equipment, was not adequately validated for its intended use. The validation did not include testing and verification of backup and restoration of the electronic data files.
Issuer: Center for Devices and Radiological Health (CDRH)