Clear Choice Therapeutics, Inc.May 11, 2023

FDA 483 - Clear Choice Therapeutics, Inc. - May 11, 2023

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Record Details

Clear Choice Therapeutics, Inc. in Raleigh, NC, was inspected regarding its manufacturing practices for medical devices. The inspection revealed a significant deficiency in quality system documentation, specifically the failure to maintain a device master record for their cleared Theia NPWT Foam Wound Dressing Kit. This indicates a serious lapse in regulatory compliance for device manufacturing.

Company: Clear Choice Therapeutics, Inc.
Inspection Date: May 11, 2023
Product Type: Device
Office: Atlanta District Office
Person: Monica C. Burgos Garcia

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ID · d1cd3e5d-bc18-4d32-9375-22b3b75a339c