# FDA 483 - Addivation Medical - January 12, 2023

Source: https://www.keypedia.com/records/483/addivation-medical/f0ed187b-c943-4baf-b49f-70c90fb335cb

> FDA 483 for Addivation Medical on January 12, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Addivation Medical
- Inspection Date: 2023-01-12
- Product Type: device
- Office Name: New Jersey District Office
- Summary: Addivation Medical, a specification developer in Chester, NJ, was inspected regarding its sterile cervical interbody implant. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate validation of sterilization processes, lack of device master records, and insufficient control over design changes, supplier quality, and labeling. These issues indicate a systemic failure to maintain proper documentation and procedures for critical aspects of medical device manufacturing and quality assurance.

## Related Officers

- [William R. Chang](https://www.keypedia.com/people/william-r-chang/67893bac-29e2-45b4-ba2c-1ef548781b9c)

Company: https://www.keypedia.com/companies/addivation-medical/81355167-f8dd-41a3-b59c-fbe3aea69004

Office: https://www.keypedia.com/offices/new-jersey-district-office/6ff5e2e9-5cff-44c7-af24-5a55329a8248