Company
United StatesAbbott Vascular, Santa Clara, CA – FDA Inspections
Inspection records and compliance data for Abbott Vascular in Santa Clara, California. 11 FDA inspections on record, 1 Form 483, last inspected December 08, 2023.
Company Profile
This profile covers Abbott Vascular based in Santa Clara, California, United States.
FDA Inspection History
- FDA inspections
- 11
- OAI
- 0
- VAI
- 1
- NAI
- 8
- Unclassified
- 2
- Form 483s
- 1
- Warning letters
- 0
First inspected September 29, 2009. Last inspected December 8, 2023.
Most cited issue areas
- Lack of or inadequate procedures1 inspection
- Report of Death or Serious Injury1 inspection
FDA inspections (11)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| December 8, 2023 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1226798 |
| October 24, 2019 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 1113177 |
| October 26, 2018 | Not classified | Medical Devices & Rad Health | 1109808 |
| November 15, 2017 | VAI | Medical Devices & Rad Health · Project Evaluation: Devices | 1031458 |
| September 14, 2017 | Not classified | Medical Devices & Rad Health | 1043550 |
| December 10, 2015 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 951125 |
| September 11, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 943736 |
| February 8, 2013 | NAI | Medical Devices & Rad Health · Compliance: Devices | 816389 |
| July 26, 2011 | NAI | Medical Devices & Rad Health · Compliance: Devices | 737472 |
| April 20, 2011 | NAI | Medical Devices & Rad Health · Bioresearch Monitoring | 721626 |
| September 29, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 616368 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Abbott Vascular
FEI Number
3004635528
Address
3200 Lakeside Dr, Santa Clara, California 95054, United States
Country
United States
ID: b9a230f1-3cfc-4a75-84cd-4bfddb45afc3