FDA Inspection
Abbott VascularAbbott Vascular – FDA Inspection, May 3, 2023
Record Details
This FDA Inspection record concerns Abbott Vascular, with an inspection on May 3, 2023, issued by the San Francisco District Office.
- Company
- Abbott Vascular
- Inspection Date
- May 3, 2023
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ID · bf6ea05e-eef4-4501-bb76-0d4f1431d323
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1204356
- FDA center
- Medical Devices & Rad Health
- Outcome
- Form 483 issued
FDA Citations
1- 21 CFR 820.90(b)(2)Product rework procedures, Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Abbott Vascular
4| Date | Classification | Office | Project area |
|---|---|---|---|
| August 11, 2017 | Not classified | San Francisco District Office | |
| August 21, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| June 3, 2010 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| May 27, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Abbott Vascular
- FDA Inspection 1044959 - 2017-08-11
- FDA Inspection 893843 - 2014-08-21
- FDA Inspection 668303 - 2010-06-03
- FDA Inspection 665884 - 2010-05-27
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