# FDA 483 - Dynasthetics LLC - January 11, 2024

Source: https://www.keypedia.com/records/483/dynasthetics-llc/d9c20169-67f4-45f6-bf26-89e1528d6803

> FDA 483 for Dynasthetics LLC on January 11, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Dynasthetics LLC
- Inspection Date: 2024-01-11
- Product Type: device
- Office Name: Denver District Office
- Summary: Dynasthetics LLC, a medical device manufacturer in Salt Lake City, UT, was cited for significant deficiencies in its quality system during an FDA inspection. Observations included a lack of process validation for critical product testing, inadequate adherence to in-process product acceptance procedures, and failures in documenting and completing corrective and preventive actions. These issues indicate a need for improved quality control and procedural compliance.

## Related Documents

- [483 - 2022-11-03](https://www.keypedia.com/records/483/dynasthetics-llc/18eec69f-dead-428c-9aa8-566bc9a37bec)

## Related Officers

- [James R. Montero](https://www.keypedia.com/people/james-r-montero/ce2d19fd-25b7-423e-9132-5d6f582380d2)

Company: https://www.keypedia.com/companies/dynasthetics-llc/803ef099-5dda-4104-9763-61690870b701

Office: https://www.keypedia.com/offices/denver-district-office/93b79063-390c-4759-af6c-5da7e388face