Company
United StatesAbbott Vascular, Barceloneta, PR – FDA Inspections
Inspection records and compliance data for Abbott Vascular in Barceloneta, Puerto Rico. 2 FDA inspections on record, last inspected August 16, 2017.
Company Profile
This profile covers Abbott Vascular based in Barceloneta, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 2
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Unclassified
- 1
- Form 483s
- 0
- Warning letters
- 0
First inspected March 12, 2012. Last inspected August 16, 2017.
Most cited issue areas
- Documentation1 inspection
- Product rework documentation, DHR {see also 820.184}1 inspection
- Records not kept1 inspection
FDA inspections (2)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 16, 2017 | Not classified | Medical Devices & Rad Health | 1040816 |
| March 12, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 775601 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Abbott Vascular
FEI Number
3005737652
Address
Building PR-17 Road #2 Km 58.0, Barceloneta, Puerto Rico 00617, United States
Country
United States
ID: b2edf6eb-7646-4e54-9be9-83fe63c77aba