483
DRE Medical Group IncDRE Medical Group Inc – FDA 483, Sep 24, 2015
Record Details
DRE Medical Group Inc, a device refurbisher, relabeler, and initial importer in Louisville, KY, was cited for significant deficiencies in its quality system. The inspection revealed a complete lack of established procedures for corrective and preventive actions, management reviews, and quality audits. These findings indicate a fundamental breakdown in the firm's quality management processes.
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ID · 9cb5d93d-d332-44af-96f7-daa0e21e2001
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