# FDA 483 - NeuroField, Inc. - May 14, 2025

Source: https://www.keypedia.com/records/483/neurofield-inc/f21424c7-8a46-47ea-b184-c10c3058d680

> FDA 483 for NeuroField, Inc. on May 14, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NeuroField, Inc.
- Inspection Date: 2025-05-14
- Product Type: device
- Office Name: Los Angeles District Office
- Summary: NeuroField, Inc. in Santa Barbara, CA, was inspected by the FDA, resulting in seven observations related to its manufacturing processes for medical devices. The inspection revealed significant deficiencies in quality system procedures, including inadequate rework procedures, lack of process validation, insufficient supplier management, incomplete design history files, and failures in complaint handling, UDI submission, and internal quality audits. These issues indicate a moderate level of non-compliance with medical device quality system regulations.

## Related Documents

- [483 - 2021-10-06](https://www.keypedia.com/records/483/neurofield-inc/90c78a34-5238-4d3f-9d72-87743904e16f)
- [WARNING_LETTER - 2021-10-06](https://www.keypedia.com/records/warning_letter/neurofield-inc/a38138d1-ad3f-4e91-a767-44b659e4b341)
- [483 - 2023-06-23](https://www.keypedia.com/records/483/neurofield-inc/4c096fa8-0066-447b-8bc9-cd36982058c2)

## Related Officers

- [Kevin N. Tran](https://www.keypedia.com/people/kevin-n-tran/dd74120c-4a8d-4fd0-9068-c862890d00d6)

Company: https://www.keypedia.com/companies/neurofield-inc/f654f932-8d5b-4c42-8e3d-362b06ef27bd

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b