FDA Inspection
Penumbra Inc.Penumbra Inc. – FDA Inspection, Jul 15, 2015
Record Details
This FDA Inspection record concerns Penumbra Inc., with an inspection on July 15, 2015, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Penumbra Inc.
- Inspection Date
- July 15, 2015
- Product Type
- Devices
View Company Profile
ID · 099b3766-015b-4227-9d31-1f79ee21df00
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 938074
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
1- 21 CFR 812.40Sponsors" general responsibilities
Full citation text and observation details available on the Dashboard.
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 |
| February 23, 2016 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 4, 2015 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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 965001 - 2016-02-23
- FDA Inspection 936229 - 2015-08-04
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