Company
United StatesIrvine Biomedical Inc, a St. Jude Medical Co., Irvine, CA – FDA Inspections
Inspection records and compliance data for Irvine Biomedical Inc, a St. Jude Medical Co. in Irvine, California. 6 FDA inspections on record, 1 Form 483, last inspected June 15, 2017.
Company Profile
This profile covers Irvine Biomedical Inc, a St. Jude Medical Co. based in Irvine, California, United States.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 0
- NAI
- 5
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected November 21, 2011. Last inspected June 15, 2017.
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| June 15, 2017 | Not classified | Medical Devices & Rad Health | 1034447 |
| April 13, 2017 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1009093 |
| November 19, 2015 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 948311 |
| June 5, 2013 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 834880 |
| March 6, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 823537 |
| November 21, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 754306 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Irvine Biomedical Inc, a St. Jude Medical Co.
FEI Number
1000519796
Address
2375 And 2382 Morse Ave, Irvine, California 92614, United States
Country
United States
ID: 68b2e9c3-c1f7-438f-874e-0e8c4ce444a9