# FDA 483 - Ximedica LLC - April 13, 2022

Source: https://www.globalkeysolutions.net/records/483/ximedica-llc/31f03c6b-5569-4f1c-8ace-969dc50f7474

> FDA 483 for Ximedica LLC on April 13, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ximedica LLC
- Inspection Date: 2022-04-13
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: 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.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/maryam-tabatabaie/b792042d-e296-446d-90a9-d30c8f635506)

Company: https://www.globalkeysolutions.net/companies/ximedica-llc/a4db7b01-32b1-4bd3-b4c1-63704a541edd

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7