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

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.