FDA Inspection
ClearPoint Neuro, Inc.ClearPoint Neuro, Inc. – FDA Inspection, Jul 25, 2018
Record Details
This FDA Inspection record concerns ClearPoint Neuro, Inc., with an inspection on July 25, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 99fd4796-7906-4dc5-9af6-3bebf0dd365d
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1060878
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 803.17Lack of Written MDR Procedures
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Other FDA inspections of ClearPoint Neuro, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| September 10, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for ClearPoint Neuro, Inc.
- FDA Inspection 895130 - 2014-09-10
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