Day

September 2, 2004
02
Sep

Roche Diagnostic Corp.

September 2, 2004
Company:Roche Diagnostic Corp..Product:Tecan Clinical Workstations, Online TDM Phenytoin diagnostic test kit Date: 9/2/04 Failure to implement procedures to ensure that all purchased products and services conform to specified requirements, as required by 21 CFR 820.50(a) and (b). Specifically, you failed to follow your procedure for adding suppliers of hardware and software accessories used in the...
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