Company
United StatesPhysio-Control, Inc., Redmond, WA – FDA Inspections
Inspection records and compliance data for Physio-Control, Inc. in Redmond, Washington. 13 FDA inspections on record (3 OAI), 2 Form 483s, last inspected April 18, 2024.
Company Profile
This profile covers Physio-Control, Inc. based in Redmond, Washington, United States.
FDA Inspection History
- FDA inspections
- 13
- OAI
- 3
- VAI
- 6
- NAI
- 4
- Form 483s
- 2
- Warning letters
- 0
First inspected February 26, 2009. Last inspected April 18, 2024.
Most cited issue areas
- Lack of or inadequate procedures4 inspections
- Design verification - Lack of or inadequate procedures2 inspections
- Identification of actions needed2 inspections
FDA inspections (13)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 18, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1230558 |
| November 26, 2019 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1111211 |
| March 29, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1086723 |
| December 15, 2017 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1035043 |
| November 18, 2016 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 994067 |
| June 26, 2015 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 931792 |
| January 17, 2014 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 863704 |
| October 24, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 808943 |
| October 24, 2012 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 806475 |
| January 5, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 640553 |
| December 18, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 642926 |
| March 30, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 576034 |
| February 26, 2009 | OAI | Medical Devices & Rad Health · Compliance: Devices | 578768 |
FDA documents
Form 483s (1)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Physio-Control, Inc.
FEI Number
3015876
Address
11811 Willows Rd Ne, Redmond, Washington 98052, United States
Country
United States
ID: cd3b1656-c525-4cfe-a3f2-d32143e20c7c