# FDA 483 - YM Dental Lab Inc. - January 17, 2025

Source: https://www.keypedia.com/records/483/ym-dental-lab-inc/459402c4-d9fa-43a6-85b7-47ef1c6bda74

> FDA 483 for YM Dental Lab Inc. on January 17, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: YM Dental Lab Inc.
- Inspection Date: 2025-01-17
- Product Type: device
- Office Name: Baltimore District Office
- Summary: YM Dental Lab Inc., a manufacturer in Chantilly, VA, was inspected by the FDA. The inspection revealed two significant observations concerning the firm's quality system. Specifically, the firm failed to adequately establish and implement procedures for both internal quality audits and management reviews, lacking proper documentation for both.

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Company: https://www.keypedia.com/companies/ym-dental-lab-inc/a86d8ca1-f466-4f75-8b13-81bd1ec4f19f

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa