DRE Medical Group IncSeptember 24, 2015

FDA 483 - DRE Medical Group Inc - September 24, 2015

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore DRE Medical Group Inc

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.

Company: DRE Medical Group Inc
Inspection Date: September 24, 2015
Product Type: Device
Office: Cincinnati District Office
Person: Teresa Kastner (Consumer Safety Officer, Medical Device Specialist)

Open in Dashboard

ID · 9cb5d93d-d332-44af-96f7-daa0e21e2001