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 devices to include:

-A record that adequate quality requirements are met.
-A record that the supplier has been sufficiently evaluated.
-A record showing the type and extent of control to be exercised over this contractor has been clearly defined.
-Established purchasing information including specified requirements for the products and services to be received.
See the 5/26/04 FDA-483 # 3.

Failure to include in the Device Master Record (DMR) for the devices a reference to the location of the device and software specifications, as required by 21 CFR 820.181. See the 6/26/04 FDA-483 # 5.

FDA District: Detroit District Office