# FDA 483 - DynaFlex - March 06, 2026

Source: https://www.keypedia.com/records/483/dynaflex/13ce12c6-cbe3-49a6-904c-0ca5dbf3947a

> FDA 483 for DynaFlex on March 06, 2026. Product: device. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: DynaFlex
- Inspection Date: 2026-03-06
- Product Type: device
- Office Name: Kansas City District Office
- Summary: Ortho Solutions LC, dba DynaFlex, a manufacturer of Class II medical devices in Lake Saint Louis, MO, received an FDA Form 483 with six observations. The inspection revealed significant quality system deficiencies, including failures in medical device reporting, unique device identification, equipment calibration, control of non-conforming products, complaint investigations, and process validation. These issues indicate a broad lack of adherence to regulatory requirements and internal procedures.

## Related Documents

- [483 - 2019-09-05](https://www.keypedia.com/records/483/dynaflex/06413c35-a161-4932-8166-3c7e07c9715b)
- [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/kansas-city-district-office/cd397ab1-df4e-46f1-ab1c-0f6db9abcf79