# FDA 483 - DynaFlex - September 05, 2019

Source: https://www.keypedia.com/records/483/dynaflex/06413c35-a161-4932-8166-3c7e07c9715b

> FDA 483 for DynaFlex on September 05, 2019. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: DynaFlex
- Inspection Date: 2019-09-05
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: Ortho Solutions LC, DBA DynaFlex, a medical device manufacturer in Saint Ann, MO, was cited for numerous quality system deficiencies during an FDA inspection. The firm failed to submit Medical Device Reports (MDRs) for serious complaints and exhibited widespread issues with design controls, process validation, and device record keeping for their orthodontic and sleep apnea devices. Many of these critical observations were repeats from a previous inspection, indicating persistent non-compliance.

## Related Documents

- [483 - 2023-09-25](https://www.keypedia.com/records/483/dynaflex/156f620d-b36e-4ab3-b744-bb1a5d0356c4)

## Related Officers

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

Company: https://www.keypedia.com/companies/dynaflex/a805d418-c220-4dcf-8f82-08ee4c075100

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