# FDA 483 - Viax Dental Lab - August 23, 2018

Source: https://www.globalkeysolutions.net/records/483/viax-dental-lab/e59f56e6-1180-41d4-879e-e80f3d0f7664

> FDA 483 for Viax Dental Lab on August 23, 2018. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Viax Dental Lab
- Inspection Date: 2018-08-23
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Viax Dental Lab, a medical device manufacturer in Alajuela, Costa Rica, received a Form FDA 483 with three observations. The inspection revealed deficiencies in design change procedures, improper labeling of Class IV laser products, and failure to submit a required annual report for a device. These findings indicate issues with the firm's quality system and regulatory compliance.

## Related Documents

- [483 - 2018-08-23](https://www.globalkeysolutions.net/records/483/viax-dental-lab/36b5dcba-5ad0-4519-9e50-6276e582bf9b)

## Related Officers

- [Shannon A. Gregory](https://www.globalkeysolutions.net/people/shannon-a-gregory/3e791321-dced-4e1d-89a1-3da91d577961)

Company: https://www.globalkeysolutions.net/companies/viax-dental-lab/32acaff3-00cd-49ab-b61e-57563cdcad8a

Office: https://www.globalkeysolutions.net/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd