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

Source: https://www.keypedia.com/records/483/clear-choice-therapeutics-inc/d1cd3e5d-bc18-4d32-9375-22b3b75a339c

> FDA 483 for Clear Choice Therapeutics, Inc. on May 11, 2023. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Clear Choice Therapeutics, Inc.
- Inspection Date: 2023-05-11
- Product Type: device
- Office Name: Atlanta District Office
- Summary: 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.

## Related Officers

- [Monica C. Burgos Garcia](https://www.keypedia.com/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.keypedia.com/companies/clear-choice-therapeutics-inc/fb589ad4-eed6-48c1-b5dd-6f2c512d2be1

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7