# FDA 483 - Lucid Diagnostics, Inc. - March 21, 2022

Source: https://www.keypedia.com/records/483/lucid-diagnostics-inc/92e9157f-d3c2-4701-bfbb-971a537fe698

> FDA 483 for Lucid Diagnostics, Inc. on March 21, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lucid Diagnostics, Inc.
- Inspection Date: 2022-03-21
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Lucid Diagnostics, Inc. in Foxborough, MA, a medical device manufacturer, identified a significant issue with the firm's complaint handling procedures. Specifically, the company failed to adequately establish and follow procedures for receiving, reviewing, and evaluating complaints, leading to an insufficient investigation of an alleged EsoCheck balloon deflation problem. This indicates a deficiency in their quality system regarding post-market surveillance and complaint management.

## Related Officers

- [Dedicated Device Cadre](https://www.keypedia.com/people/dedicated-device-cadre/693932db-dd86-453f-9b51-a63444b07281)
- [investigator](https://www.keypedia.com/people/john-a-sciacchitano/9f8f49bf-1971-449e-972e-b516418ea78e)

Company: https://www.keypedia.com/companies/lucid-diagnostics-inc/a55b122d-6600-4f86-a40a-a25bd83e7d14

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94