1. Failure to validate major equipment used in the manufacture of medical devices (i.e. computer-driven Kiwa mills, Mori Seiki SL2B lathe, and Citizen lathes);
1. Failure to validate major equipment used in the manufacture of medical devices (i.e. computer-driven Kiwa mills, Mori Seiki SL2B lathe, and Citizen lathes);
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