FDA Inspection 1295802 — NeuroCareAI, Inc.
The FDA completed an inspection of NeuroCareAI, Inc. on Dec 12, 2025 in Prosper, TX. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 12, 2025
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Prosper, TX (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22798 | 21 CFR 801.50(a) | Labeling requirements for stand-alone software |
| 3147 | 21 CFR 820.170(a) | Lack of or inadequate instructions |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |