DRE Medical Group IncFebruary 21, 2019

FDA 483 - DRE Medical Group Inc - February 21, 2019

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Record Details

An FDA inspection of DRB Medical Group Inc in Louisville, KY, conducted from February 12-21, 2019, identified a significant issue regarding the firm's complaint handling system. The inspection revealed that records of complaint investigations lacked required information, specifically inadequate documentation of investigation activities. This indicates a deficiency in the firm's quality system pertaining to complaint management.

Company: DRE Medical Group Inc
Inspection Date: February 21, 2019
Product Type: Other
Office: Cincinnati District Office
Person: Shannon A. Gregory

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ID · 0587f253-d548-4f36-92bd-42f3ffc7f3f0