# FDA 483 - Ordont Orthodontic Laboratories Inc - February 08, 2024

Source: https://www.globalkeysolutions.net/records/483/ordont-orthodontic-laboratories-inc/a45793fe-c81d-4ce5-93d2-bcf5903865eb

> FDA 483 for Ordont Orthodontic Laboratories Inc on February 08, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ordont Orthodontic Laboratories Inc
- Inspection Date: 2024-02-08
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Ordont Orthodontic Laboratories Inc. in Fenton, MO, a medical device manufacturer, was cited for numerous significant quality system deficiencies during an FDA inspection. The firm failed to implement basic quality system requirements, including UDI labeling, GUDID submission, design history files, complaint handling, CAPA, device history records, training, and quality audits. These widespread issues indicate a severe lack of control over their manufacturing processes and product quality for their Invisible SmileSeries orthodontic brackets.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/ordont-orthodontic-laboratories-inc/3472615d-5285-4831-9d9e-597436ab4618

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