# FDA 483 - Thoracent, LLC - December 11, 2025

Source: https://www.keypedia.com/records/483/thoracent-llc/31b602e8-4e0b-421d-91af-556ebbbcdc75

> FDA 483 for Thoracent, LLC on December 11, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Thoracent, LLC
- Inspection Date: 2025-12-11
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: An FDA inspection of Thoracent, LLC in Huntington, NY, identified significant deficiencies in their quality system. The firm failed to establish written procedures for Medical Device Reporting (MDRs), complaint handling, and corrective and preventive actions. These observations indicate a lack of fundamental controls for managing product quality and safety.

## Related Officers

- [Preston M. Lee](https://www.keypedia.com/people/preston-m-lee/e44adac3-a915-4bfb-8b06-a41ea5803358)

Company: https://www.keypedia.com/companies/thoracent-llc/df9ac7e0-55e1-4c48-9021-4fe7ce70536c

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961