Company
United StatesPublic company, NYSE: PENPenumbra Inc. (NYSE: PEN), Alameda, CA – FDA Inspections
Inspection records and compliance data for Penumbra Inc. in Alameda, California. 11 FDA inspections on record (1 OAI), 1 Form 483, last inspected June 21, 2021. Publicly traded as NYSE: PEN.
Company Profile
This profile covers Penumbra Inc. based in Alameda, California, United States.
FDA Inspection History
- FDA inspections
- 11
- OAI
- 1
- VAI
- 4
- NAI
- 5
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 26, 2009. Last inspected June 21, 2021.
Most cited issue areas
- CAPA verification/validation of corrective/preventive action1 inspection
- General1 inspection
- Identification of actions needed1 inspection
FDA inspections (11)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 21, 2021 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1145527 |
| June 13, 2018 | Not classified | Medical Devices & Rad Health | 1065797 |
| February 13, 2017 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1002192 |
| February 23, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 965001 |
| August 4, 2015 | VAI | Medical Devices & Rad Health · Compliance: Devices | 936229 |
| July 15, 2015 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 938074 |
| April 30, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 876601 |
| February 27, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 769596 |
| August 24, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 676922 |
| August 28, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 614070 |
| February 26, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 578236 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Penumbra Inc.
Stock ticker
PEN
Exchange
NYSE
Share price
$321.04
Market cap
$12.7B
Price as of
November 6, 2026
FEI Number
3005168196
Address
1 Penumbra, Alameda, California 94502, United States
Country
United States
ID: 8b3e95a4-a5b1-40f4-9baf-8dfc5e2d64e4