April 1, 2004
Recipient:Cordis Corporation Product: Sirolimus-Eluting Coronary Stent Date: 4/1/2004 Failure to validate with a high degree of assurance, processes, including changed processes, that cannot be fully verified by subsequent investigation and test, as required by 21 CFR 820.75(a) & (c). For example: The automated [redacted] data acquisition system, used to ensure the integrity of the analytical...
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Company: Cordis Corp.Product: “Cypher Sirolimus-Eluting Coronary Stent” Date: 4/1/04 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...
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