# FDA 483 - Xeridiem Medical Devices, Inc. - February 07, 2020

Source: https://www.globalkeysolutions.net/records/483/xeridiem-medical-devices-inc/f9bd1098-3167-4f67-bb04-28e988bd866e

> FDA 483 for Xeridiem Medical Devices, Inc. on February 07, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Xeridiem Medical Devices, Inc.
- Inspection Date: 2020-02-07
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Westliem Medical Devices, Inc. in Tucson, AZ, revealed significant deficiencies in their quality system. Observations included inadequate documentation for validated processes, specifically regarding acceptance criteria and dimensional verification. Furthermore, the firm failed to implement written Medical Device Report (MDR) procedures, resulting in multiple delayed submissions for incidents involving serious injury and patient death.

## Related Officers

- [Eric C. Fox](https://www.globalkeysolutions.net/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.globalkeysolutions.net/companies/xeridiem-medical-devices-inc/9a455ccf-9d0a-42ee-9a96-4ca57f90bf4d

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6