# FDA 483 - Crystalmark Dental Systems Inc - October 22, 2021

Source: https://www.globalkeysolutions.net/records/483/crystalmark-dental-systems-inc/2ed64016-4c3a-431d-b727-e7796368bd9c

> FDA 483 for Crystalmark Dental Systems Inc on October 22, 2021. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Crystalmark Dental Systems Inc
- Inspection Date: 2021-10-22
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Crystalmark Dental Systems Inc. in Glendale, CA, a medical device manufacturer, revealed significant deficiencies in their quality system. Observations included inadequate medical device reporting procedures, insufficient training for management, and a lack of established procedures for controlling nonconforming products. These issues indicate a need for comprehensive improvements in their quality management system.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/sarah-a-hassas/4f142d54-fc28-4bd5-82ad-7e6fa443688c)

Company: https://www.globalkeysolutions.net/companies/crystalmark-dental-systems-inc/e6629cff-f33f-4fff-9758-eee972ad8ffa

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6