Company
United StatesSt. Jude Medical, Atrial Fibrillation Division, Inc., Saint Paul, MN – FDA Inspections
Inspection records and compliance data for St. Jude Medical, Atrial Fibrillation Division, Inc. in Saint Paul, Minnesota. 4 FDA inspections on record, 2 Form 483s, last inspected March 29, 2019.
Company Profile
This profile covers St. Jude Medical, Atrial Fibrillation Division, Inc. based in Saint Paul, Minnesota, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 0
- NAI
- 3
- Unclassified
- 1
- Form 483s
- 2
- Warning letters
- 0
First inspected July 27, 2017. Last inspected March 29, 2019.
Most cited issue areas
- Design output - documentation1 inspection
- Design plans - Lack of or inadequate1 inspection
- Design verification - output does not meet input requirement1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| March 29, 2019 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 1084607 |
| May 17, 2018 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1053126 |
| September 28, 2017 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1029059 |
| July 27, 2017 | Not classified | Medical Devices & Rad Health | 1034622 |
FDA documents
Form 483s (1)
People (1)
Related Companies (10)
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Company Information
Name
St. Jude Medical, Atrial Fibrillation Division, Inc.
FEI Number
1000139754
Address
1 Saint Jude Medical Dr, Saint Paul, Minnesota 55117, United States
Country
United States
ID: 13104c54-1508-4936-a3a0-6969e09a1466