# FDA 483 - NeuroCareAI, Inc. - December 12, 2025

Source: https://www.keypedia.com/records/483/neurocareai-inc/f7273be9-91eb-463d-bf71-0d5c45d5d89b

> FDA 483 for NeuroCareAI, Inc. on December 12, 2025. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: NeuroCareAI, Inc.
- Inspection Date: 2025-12-12
- Product Type: device
- Office Name: Dallas District Office
- Summary: NeuroCareAI, Inc. dba SaveLife AI, Inc. in Prosper, TX, received a Form FDA 483 with four observations following an inspection. The firm was cited for significant deficiencies in its quality system, including a lack of internal quality audits and inadequate supplier management. Additionally, issues were noted with the establishment of installation and test procedures, and the failure to implement unique device identifiers for its Neurocare ICH standalone software medical device.

## Related Officers

- [Yuliana Hernandez-Magana](https://www.keypedia.com/people/yuliana-hernandez-magana/450c3c39-02b7-489d-a710-e8c87c7657f4)
- [Jacey Roy](https://www.keypedia.com/people/jacey-roy/6c4d5a32-4aa3-43b0-a06f-40757863219e)

Company: https://www.keypedia.com/companies/neurocareai-inc/7e50b166-02aa-4c1a-affb-722d717c9112

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9