# FDA 483 - Coapt LLC - November 02, 2022

Source: https://www.globalkeysolutions.net/records/483/coapt-llc/af5464fa-05fd-4dfc-aa1b-f798c53b3ce3

> FDA 483 for Coapt LLC on November 02, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Coapt LLC
- Inspection Date: 2022-11-02
- Product Type: device
- Office Name: Chicago District Office
- Summary: Coapt LLC in Chicago, IL, was inspected from October 28 to November 2, 2022, and received a Form FDA 483 with three observations. The inspection revealed significant deficiencies including the failure to submit a Medical Device Report for a device malfunction causing patient burns, lack of justification for not reporting a correction action to the FDA, and inadequate maintenance of document change records for their hazard matrix. These issues indicate a need for improved quality system controls.

## Related Documents

- [483 - 2019-12-11](https://www.globalkeysolutions.net/records/483/coapt-llc/65fca4fa-18f0-4555-b2fc-1a785980131e)

## Related Officers

- [Brittani N. Franklin](https://www.globalkeysolutions.net/people/brittani-n-franklin/1d5e9344-1145-42ff-a175-5541b565b15e)

Company: https://www.globalkeysolutions.net/companies/coapt-llc/32959b76-e0c9-422d-92e7-d12579b7020c

Office: https://www.globalkeysolutions.net/offices/chicago-district-office/a510300b-0eaf-4a33-90b5-231d95977669