Ximedica LLCApril 13, 2022

FDA 483 - Ximedica LLC - April 13, 2022

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Record Details

An FDA inspection of Ximedica LLC, a contract manufacturer in Providence, RI, identified a significant issue related to design validation. The firm failed to adequately validate a design using initial production units manufactured under defined operating conditions, indicating a lapse in quality system requirements. This single observation suggests a moderate severity finding concerning product development and manufacturing controls.

Company: Ximedica LLC
Inspection Date: April 13, 2022
Product Type: Device
Office: Division of Northeast Imports
Person: Maryam Tabatabaie (issuing_officer)

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ID · 31f03c6b-5569-4f1c-8ace-969dc50f7474