Company
United StatesSt. Jude Medical, Minnetonka, MN – FDA Inspections
Inspection records and compliance data for St. Jude Medical in Minnetonka, Minnesota. 8 FDA inspections on record (1 OAI), last inspected March 20, 2019.
Company Profile
This profile covers St. Jude Medical based in Minnetonka, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 1
- VAI
- 2
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected December 19, 2008. Last inspected March 20, 2019.
Most cited issue areas
- Dissemination of problem information1 inspection
- Documentation1 inspection
- Implementing changes1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 20, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1089439 |
| April 11, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 967750 |
| July 31, 2014 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 903706 |
| February 28, 2012 | NAI | Medical Devices & Rad Health · Compliance: Devices | 771571 |
| April 21, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 721939 |
| March 1, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 712895 |
| January 22, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 646942 |
| December 19, 2008 | OAI | Medical Devices & Rad Health · Compliance: Devices | 553243 |
FDA documents
EIRs (1)
People (2)
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
St. Jude Medical
FEI Number
2182269
Address
14901 Deveau Pl, Minnetonka, Minnesota 55345, United States
Country
United States
ID: 6a128c52-c91a-4fc6-9df3-d5d6161c49bd