FDA Inspection
Pulsar Vascular Inc.Pulsar Vascular Inc. – FDA Inspection, Mar 1, 2017
Record Details
This FDA Inspection record concerns Pulsar Vascular Inc., with an inspection on March 1, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · f06ca2b3-d456-43fb-ad20-be6f378bcee6
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1003264
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.30(e)Design review - Lack of or inadequate procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
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Other FDA inspections of Pulsar Vascular Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| September 15, 2016 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| November 13, 2015 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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