# FDA 483 - Device Masters Dental Laboratory L.L.C. - November 07, 2018

Source: https://www.globalkeysolutions.net/records/483/device-masters-dental-laboratory-llc/6b37b992-1c26-411d-aec6-67d12eb8ad4e

> FDA 483 for Device Masters Dental Laboratory L.L.C. on November 07, 2018. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Device Masters Dental Laboratory L.L.C.
- Inspection Date: 2018-11-07
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations III
- Summary: An FDA inspection of Device Masters Dental Laboratory L.L.C. in Williamsburg, MI, a medical device establishment, revealed a significant issue with their supplier management. The firm failed to adequately establish procedures to ensure purchased products and services conform to specified requirements, specifically regarding the approval and monitoring of suppliers. This indicates a moderate severity issue related to quality system controls for medical devices.

## Related Documents

- [483 - 2018-11-07](https://www.globalkeysolutions.net/records/483/device-masters-dental-laboratory-llc/363daa3a-3eb4-4625-b1e2-91d66d6272fb)

## Related Officers

- [David J. Gasparovich](https://www.globalkeysolutions.net/people/david-j-gasparovich/478888db-d4b3-481a-89f5-ee234a160f07)

Company: https://www.globalkeysolutions.net/companies/device-masters-dental-laboratory-llc/87c91d75-0f98-4cc3-8cf7-979664210ea3

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iii/45bc2d0d-d731-4955-aeb5-59aa0b76e4f0