# FDA 483 - DynaFlex - September 25, 2023

Source: https://www.keypedia.com/records/483/dynaflex/156f620d-b36e-4ab3-b744-bb1a5d0356c4

> FDA 483 for DynaFlex on September 25, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: DynaFlex
- Inspection Date: 2023-09-25
- 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 Lake Saint Louis, MO, was cited for significant deficiencies during an FDA inspection. The firm failed to adequately establish procedures for complaint handling, equipment calibration, process revalidation, and supplier management. These issues indicate potential risks to device quality and patient safety, particularly concerning their Class 2 sleep devices.

## Related Documents

- [483 - 2019-09-05](https://www.keypedia.com/records/483/dynaflex/06413c35-a161-4932-8166-3c7e07c9715b)

## 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