# FDA 483 - Motion Concepts LP - November 16, 2023

Source: https://www.keypedia.com/records/483/motion-concepts-lp/585d3958-f627-4998-96bf-57895e7ceac8

> FDA 483 for Motion Concepts LP on November 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Motion Concepts LP
- Inspection Date: 2023-11-16
- Product Type: device
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Motion Concepts LP, a medical device manufacturer in Concord, was inspected by the FDA, resulting in three observations. The inspection revealed deficiencies in the firm's quality system, specifically concerning inadequate documentation of corrective and preventive actions, insufficient establishment of supplier requirements, and non-objective risk analysis procedures. These issues indicate potential weaknesses in ensuring product safety and quality.

## Related Officers

- [Investigator ](https://www.keypedia.com/people/benjamin-j-dastoli/688c2ad7-f7ac-47eb-8ca2-4efcd221f636)

Company: https://www.keypedia.com/companies/motion-concepts-lp/0c72d0aa-bac5-4b41-9865-ed2760eb336d

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd