FDA Inspection
Penumbra Inc.Penumbra Inc. – FDA Inspection, Feb 23, 2016
Record Details
This FDA Inspection record concerns Penumbra Inc., with an inspection on February 23, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Penumbra Inc.
- Inspection Date
- February 23, 2016
- Product Type
- Devices
View Company Profile
ID · 8946649a-6efd-460d-ba42-079ec87daccd
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 965001
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
Other FDA inspections of Penumbra Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| June 21, 2021 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 13, 2018 | Not classified | San Francisco District Office | |
| February 13, 2017 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| August 4, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 15, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Penumbra Inc.
- FDA Inspection 1145527 - 2021-06-21
- FDA Inspection 1065797 - 2018-06-13
- FDA Inspection 1002192 - 2017-02-13
- FDA Inspection 936229 - 2015-08-04
- FDA Inspection 938074 - 2015-07-15
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