483
Diagnostic Automation/Cortez Diagnostics IncDiagnostic Automation/Cortez Diagnostics Inc – FDA 483, Jul 15, 2021
Record Details
Diagnostic Automation/Cortez Diagnostics Inc. in Irvine, CA, underwent an FDA inspection from July 13-15, 2021, which revealed a significant deficiency in their process control procedures. The firm failed to adequately establish procedures for recording in-process non-conformities during the relabeling/repacking of Class II IVD kits. This indicates a moderate severity issue related to quality system compliance.
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ID · 534524bf-1a8f-4cf3-a02e-b3634d8706d2
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