# FDA 483 - May Dental Arts, LLC - December 06, 2023

Source: https://www.keypedia.com/records/483/may-dental-arts-llc/2eb7a5be-7527-4b3a-82b5-e57b4cf90c68

> FDA 483 for May Dental Arts, LLC on December 06, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: May Dental Arts, LLC
- Inspection Date: 2023-12-06
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: May Dental Arts, LLC, a medical device contract manufacturer in Fenton, MO, was cited with five observations during an FDA inspection. The firm failed to properly label its Class II medical devices with Unique Device Identifiers (UDI) and did not submit required information to the Global Unique Device Identification Database (GUDID). Additionally, the inspection revealed inadequate labeling procedures, a lack of a device master record, and unvalidated manufacturing processes for implant restorations.

## Related Officers

- [Edward E. Lockwood](https://www.keypedia.com/people/edward-e-lockwood/3260b39e-9211-489f-8247-0ec3353e57ca)

Company: https://www.keypedia.com/companies/may-dental-arts-llc/2f11217d-aa3c-4657-9152-c983a099ad00

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8