# FDA 483 - Neuromechanical Innovations, LLC - December 13, 2023

Source: https://www.globalkeysolutions.net/records/483/neuromechanical-innovations-llc/8bac68db-c3ca-41cd-8226-28107560a288

> FDA 483 for Neuromechanical Innovations, LLC on December 13, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neuromechanical Innovations, LLC
- Inspection Date: 2023-12-13
- Product Type: device
- Office Name: Denver District Office
- Summary: Neuromechanical Innovations, LLC, a medical device manufacturer in Chandler, AZ, was cited for significant deficiencies during an FDA inspection. The firm failed to include unique device identifiers (UDI) on medical device labels for its Impulse/Impulse iQ adjustment tools. Additionally, the company had not conducted required management reviews or quality audits for the past two years, indicating a lapse in quality system oversight.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/charles-l-larson/4232255d-bfd6-4616-a854-c801e4c23e1c)

Company: https://www.globalkeysolutions.net/companies/neuromechanical-innovations-llc/7ac608e7-a2a6-4e98-9b00-33be23a791b7

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