# FDA 483 - AMT Medical - December 13, 2019

Source: https://www.globalkeysolutions.net/records/483/amt-medical/9bc9122f-25b4-4188-aab7-b79bfe55b36c

> FDA 483 for AMT Medical on December 13, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: AMT Medical
- Inspection Date: 2019-12-13
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West VI
- Summary: Advantage Manufacturing Technologies, Inc. in Monroe, WA, a contract manufacturer of Class 2 implantable bone screws and plates, was cited for two observations during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, specifically not verifying the full implementation of a corrective action. Additionally, evaluations of out-of-calibration equipment and associated remedial actions were not documented.

## Related Officers

- [Stephen R. Souza](https://www.globalkeysolutions.net/people/stephen-r-souza/9b7af4df-f1cc-468d-9761-cee11d3c14fc)

Company: https://www.globalkeysolutions.net/companies/amt-medical/7d361ca8-f271-4574-9af9-ad5f413324a5

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-vi/6e5a2a08-f464-4979-a759-7b0383370822