Silex Medical, LLCJune 11, 2019

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

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Record Details

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.

Company: Silex Medical, LLC
Inspection Date: June 11, 2019
Product Type: Device
Office: Division of Northeast Imports
Person: Michael G. Mayfield (investigator)

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ID · 2b0faa8b-ce56-4918-b5d6-4083f3975a78