# FDA 483 - Pacific Medical Group, Inc. DBA Avante Health Solutions - September 24, 2021

Source: https://www.keypedia.com/records/483/pacific-medical-group-inc-dba-avante-health-solutions/2a19f987-c9dd-4660-adb4-5448a86014ab

> FDA 483 for Pacific Medical Group, Inc. DBA Avante Health Solutions on September 24, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Pacific Medical Group, Inc. DBA Avante Health Solutions
- Inspection Date: 2021-09-24
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Pacific Medical Group, Inc., a servicer/remanufacturer in San Clemente, CA, was cited for significant deficiencies in its quality system during an FDA inspection. The inspection revealed inadequate procedures for complaint handling, ineffective corrective and preventive actions, incomplete service reports, and a lack of control over non-conforming products. These issues indicate a systemic failure to ensure proper documentation and evaluation of device issues and repairs.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/paul-m-kawamoto/0a24b110-12de-4736-8d98-7a023ceec01e)

Company: https://www.keypedia.com/companies/pacific-medical-group-inc-dba-avante-health-solutions/d3ecdbef-bc49-489d-a839-cce08e6bb67c

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