FDA Inspection
Pulse Biomedical IncPulse Biomedical Inc – FDA Inspection, Nov 6, 2017
Record Details
This FDA Inspection record concerns Pulse Biomedical Inc, with an inspection on November 6, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a76e77f2-1c12-43c2-a18d-885a67ca3785
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1030842
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.198(a)Complaints
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Other FDA inspections of Pulse Biomedical Inc
3| Date | Classification | Office | Project area |
|---|---|---|---|
| March 5, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| October 23, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 16, 2009 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Pulse Biomedical Inc
- FDA Inspection 915470 - 2015-03-05
- FDA Inspection 808339 - 2012-10-23
- FDA Inspection 601767 - 2009-07-16
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