Day

November 19, 2004
19
Nov

Ortek AG

November 19, 2004
Company: Ortek AGProduct: Shoulder, hip and knee prostheses Date: 11/19/04 Failure to validate computer software for its intended use for computers or automated data processing systems used as part of production or the quality system, as required by 21 CFR 820.70(i). For example, the software used to control the automated _____ used to produce medical...
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