# FDA 483 - iCE Neurosystems, Inc. - November 06, 2024

Source: https://www.keypedia.com/records/483/ice-neurosystems-inc/26cb17fc-55a7-4ef5-8aaa-5add8cd963f2

> FDA 483 for iCE Neurosystems, Inc. on November 06, 2024. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: iCE Neurosystems, Inc.
- Inspection Date: 2024-11-06
- Product Type: device
- Office Name: Baltimore District Office
- Summary: iCE Neurosystems, Inc. in Washington, DC, a medical device manufacturer, received a Form FDA-483 with four observations during an inspection. The firm failed to adequately establish and implement critical quality system procedures, including those for acceptance activities, software validation, management review, and internal audits. These deficiencies indicate significant issues within their quality management system.

## Related Officers

- [Tiki Dixon](https://www.keypedia.com/people/tiki-dixon/b3160a2c-ef16-4fa2-b9b9-4c3a0ed17c5b)

Company: https://www.keypedia.com/companies/ice-neurosystems-inc/e8eff30c-bce0-4814-963e-841f2efbbe8a

Office: https://www.keypedia.com/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa