Company
United StatesSt. Jude Medical, Atlanta, GA – FDA Inspections
Inspection records and compliance data for St. Jude Medical in Atlanta, Georgia. 7 FDA inspections on record (3 OAI), last inspected August 13, 2024.
Company Profile
This profile covers St. Jude Medical based in Atlanta, Georgia, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 3
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected March 21, 2011. Last inspected August 13, 2024.
Most cited issue areas
- Documentation2 inspections
- Lack of or inadequate procedures2 inspections
- Production processes2 inspections
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 13, 2024 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1241032 |
| March 20, 2018 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1049574 |
| July 28, 2016 | VAI | Medical Devices & Rad Health · Compliance: Devices | 980509 |
| June 26, 2015 | OAI | Medical Devices & Rad Health · Compliance: Devices | 932468 |
| November 30, 2011 | OAI | Medical Devices & Rad Health · Bioresearch Monitoring | 760323 |
| June 15, 2011 | OAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 736134 |
| March 21, 2011 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 717752 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
St. Jude Medical
FEI Number
3004936110
Address
387 Technology Cir Nw Ste 500, Atlanta, Georgia 30313, United States
Country
United States
ID: 185154f3-72ab-4158-b0e2-7eeeb47c0709