# FDA 483 - Silex Medical, LLC - June 11, 2019

Source: https://www.keypedia.com/records/483/silex-medical-llc/2b0faa8b-ce56-4918-b5d6-4083f3975a78

> FDA 483 for Silex Medical, LLC on June 11, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Silex Medical, LLC
- Inspection Date: 2019-06-11
- Product Type: device
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Gilex Medical, LLC, a laparoscopic instrument manufacturer in Southington, CT, revealed significant deficiencies in their quality system. The firm was cited for inadequate procedures related to complaint handling, corrective and preventive actions, and routine equipment maintenance. These observations indicate a need for comprehensive procedural updates and improved documentation practices.

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## Related Officers

- [investigator](https://www.keypedia.com/people/michael-g-mayfield/ec045e12-d940-4f76-a17f-98ba4a8dd5b9)

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

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