Company
United StatesSt Jude Medical Inc, Saint Paul, MN – FDA Inspections
Inspection records and compliance data for St Jude Medical Inc in Saint Paul, Minnesota. 4 FDA inspections on record, last inspected May 06, 2014.
Company Profile
This profile covers St Jude Medical Inc based in Saint Paul, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 2
- NAI
- 2
- Form 483s
- 0
- Warning letters
- 0
First inspected March 25, 2010. Last inspected May 6, 2014.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Lack of or inadequate procedures1 inspection
- Lack of Written MDR Procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 6, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 878348 |
| October 3, 2012 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 801786 |
| September 21, 2010 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 681486 |
| March 25, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 651144 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
St Jude Medical Inc
FEI Number
2126673
Address
1 Lillehei Plz, Saint Paul, Minnesota 55117, United States
Country
United States
ID: 8ed7e7c9-f517-4a8c-b2a2-102f237e8151