FDA Inspection
NeuroField, Inc.NeuroField, Inc. – FDA Inspection, Feb 23, 2018
Record Details
This FDA Inspection record concerns NeuroField, Inc., with an inspection on February 23, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · efab9ab1-8e47-4676-9816-860de13a439e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1042102
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
8- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.20(b)Lack of or inadequate organizational structure
- 21 CFR 820.30(g)Design validation - software validation not performed
- 21 CFR 820.50(a)(3)Acceptable supplier records, inadequate records
- 21 CFR 820.70(i)Software validation for automated processes
- 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of NeuroField, Inc.
3| Date | Classification | Office | Project area |
|---|---|---|---|
| May 14, 2025 | Not classified | Los Angeles District Office | Compliance: Medical Devices |
| June 23, 2023 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 6, 2021 | OAI | Center for Devices and Radiological Health | Compliance: Devices |
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