# FDA 483 - CSA Medical - March 23, 2026

Source: https://www.keypedia.com/records/483/csa-medical/d618c937-e4f5-4065-b605-a31bbfc2b80a

> FDA 483 for CSA Medical on March 23, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CSA Medical
- Inspection Date: 2026-03-23
- Product Type: device
- Office Name: New England District Office
- Summary: An FDA inspection of CSA Medical, Inc. in Lexington, MA, conducted from March 17-23, 2026, identified deficiencies in the firm's quality system. The primary issue concerned inadequate documentation of procedures and files related to nonconforming products. Specifically, nonconforming files lacked proper justification for corrective actions, determination of required actions, and evidence of trending.

## Related Officers

- [Thomas Siebertz](https://www.keypedia.com/people/thomas-siebertz/a2547520-c652-4303-822c-e32648dc9b01)
- [Nabil Nakhoul](https://www.keypedia.com/people/nabil-nakhoul/d676e9c9-566c-4e59-84e8-1dc474e4e48d)

Company: https://www.keypedia.com/companies/csa-medical/5fd9537f-0dde-489c-b6f7-6204d87bdf81

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144