# FDA 483 - Custom Milling Center Inc - July 16, 2019

Source: https://www.keypedia.com/records/483/custom-milling-center-inc/df3919b5-f164-4e15-be64-6f0a4b33ce9d

> FDA 483 for Custom Milling Center Inc on July 16, 2019. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Custom Milling Center Inc
- Inspection Date: 2019-07-16
- Product Type: device
- Office Name: Denver District Office
- Summary: Custom Milling Center Inc, a contract manufacturer in Golden, CO, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately validate manufacturing processes for dental abutments and exhibited widespread issues across its quality management, including inadequate CAPA, complaint handling, nonconforming product control, and documentation practices. These observations indicate a systemic lack of established and followed procedures for critical medical device manufacturing operations.

## Related Officers

- [investigator](https://www.keypedia.com/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

Company: https://www.keypedia.com/companies/custom-milling-center-inc/69acfbe3-6764-4692-89a6-e89f2dbefd72

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face