Dental Choice Holdings LlcApril 26, 2022

FDA 483 - Dental Choice Holdings Llc - April 26, 2022

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Record Details

An FDA inspection of Dental Choice Holding Llc in Louisville, KY, revealed two significant observations. The firm failed to adequately establish procedures for receiving, reviewing, and evaluating complaints, with no documented investigations for customer service records. Additionally, procedures for acceptance activities and documentation of device specifications prior to commercial release were not adequately established.

Company: Dental Choice Holdings Llc
Inspection Date: April 26, 2022
Product Type: Device
Office: Cincinnati District Office
Person: Shannon A. Gregory

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ID · 4fd22c76-5376-4e5e-9887-624a780c4d86