# FDA 483 - Silex Medical, LLC - April 23, 2025

Source: https://www.keypedia.com/records/483/silex-medical-llc/e24af4c0-d58f-4b39-8fcf-24ada8d52388

> FDA 483 for Silex Medical, LLC on April 23, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Silex Medical, LLC
- Inspection Date: 2025-04-23
- Product Type: device
- Office Name: New England District Office
- Summary: Silex Medical, LLC, a medical device manufacturer in Southington, CT, was cited for six significant quality system deficiencies during an FDA inspection. Key issues include failures in reporting device corrections and removals, lack of risk analysis, inadequate control of nonconforming products, and deficiencies in corrective and preventive action procedures. The inspection also highlighted problems with finished device acceptance and a repeat observation regarding inadequate complaint handling.

## Related Documents

- [483 - 2019-06-11](https://www.keypedia.com/records/483/silex-medical-llc/2b0faa8b-ce56-4918-b5d6-4083f3975a78)

## Related Officers

- [Katarzyna Plona](https://www.keypedia.com/people/katarzyna-plona/ea20d6c6-5d2d-41a0-a755-0647fb9f3250)

Company: https://www.keypedia.com/companies/silex-medical-llc/218e6dd8-5da5-44d6-a66d-2b9700bb600f

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