# FDA 483 - Neuromonics Inc. - January 09, 2020

Source: https://www.keypedia.com/records/483/neuromonics-inc/0b6330a2-9d29-4d63-a913-5cce5bea73ee

> FDA 483 for Neuromonics Inc. on January 09, 2020. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Neuromonics Inc.
- Inspection Date: 2020-01-09
- Product Type: device
- Office Name: Denver District Office
- Summary: Neuromonics Inc., a medical device manufacturer in Westminster, CO, received an FDA Form 483 citing nine observations related to its quality system. The inspection revealed systemic deficiencies in maintaining and implementing procedures for critical areas such as MDR reporting, complaint handling, nonconforming product control, process controls, acceptance activities, device history records, supplier management, management review, and quality audits. These issues indicate a significant lack of adherence to established quality system requirements.

## Related Officers

- [investigator](https://www.keypedia.com/people/christine-i-shaw/480cb61e-f173-432d-b84a-c8b492192302)

Company: https://www.keypedia.com/companies/neuromonics-inc/9b06f057-7f4b-4f36-b94d-9aa0e24d2edf

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