# FDA 483 - Scientific Analytics/DARI Motion, Overland Park, KS USA - August 26, 2021

Source: https://www.globalkeysolutions.net/records/483/scientific-analyticsdari-motion-overland-park-ks-usa/ab3814f3-77d2-4c89-b7a5-210c3a741064

> FDA 483 for Scientific Analytics/DARI Motion, Overland Park, KS USA on August 26, 2021. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Scientific Analytics/DARI Motion, Overland Park, KS USA
- Inspection Date: 2021-08-26
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: An FDA inspection of DARI Motion, Inc. in Overland Park, KS, a manufacturer of the Class II DARI Health Interactive Rehabilitation Exercise system, revealed significant deficiencies across its quality management system. The firm failed to establish or adequately maintain fundamental procedures for design control, corrective and preventive actions, device master records, acceptance activities, complaint handling, quality audits, training, and management review. These widespread issues indicate a severe lack of compliance with medical device quality system regulations.

## Related Documents

- [483 - 2022-11-10](https://www.globalkeysolutions.net/records/483/scientific-analyticsdari-motion-overland-park-ks-usa/eeeff990-d66a-46eb-8b5c-db3d63f5079a)

## Related Officers

- [Clifford F. Long](https://www.globalkeysolutions.net/people/clifford-f-long/846e5a0c-cb7c-421c-86aa-be9fddfbaaba)
- [Eric C. Fox](https://www.globalkeysolutions.net/people/eric-c-fox/218af117-1551-476f-80ba-172e2cd6baee)

Company: https://www.globalkeysolutions.net/companies/scientific-analyticsdari-motion-overland-park-ks-usa/3ba9e519-2cf7-4f3e-adf5-e6c5a34c252a

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