# FDA 483 - North American Medical Corp. (NAM) - December 09, 2022

Source: https://www.globalkeysolutions.net/records/483/north-american-medical-corp-nam/981c2342-6662-42cf-b1e6-da6c7de1f42d

> FDA 483 for North American Medical Corp. (NAM) on December 09, 2022. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: North American Medical Corp. (NAM)
- Inspection Date: 2022-12-09
- Product Type: device
- Office Name: Atlanta District Office
- Summary: An FDA inspection of North American Medical Corp. (NAM) in Marietta, GA, identified significant deficiencies in their quality system related to the SPINA System with cervical/Accu-SPINA model 21. Observations included a lack of established process control procedures for PFMEA documents, inadequate training procedures and records, and insufficient documentation of rework activities in device history records. These findings indicate a need for improved quality system controls to ensure product quality and regulatory compliance.

## Related Officers

- [Monica C. Burgos Garcia](https://www.globalkeysolutions.net/people/monica-c-burgos-garcia/d73d6ad6-4158-4c12-a0bf-6f5721db3400)

Company: https://www.globalkeysolutions.net/companies/north-american-medical-corp-nam/a385cb5e-4cb3-4afa-a18f-770b844d0d30

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7