FDA Inspection
Abbott VascularAbbott Vascular – FDA Inspection, Nov 15, 2017
Record Details
This FDA Inspection record concerns Abbott Vascular, with an inspection on November 15, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · e5d58afe-dc04-4002-b14d-afdbde356db1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1031458
- FDA center
- Medical Devices & Rad Health
- Project area
- Project Evaluation: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Abbott Vascular
10| Date | Classification | Office | Project area |
|---|---|---|---|
| December 8, 2023 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| October 24, 2019 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| October 26, 2018 | Not classified | San Francisco District Office | |
| September 14, 2017 | Not classified | San Francisco District Office | |
| December 10, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Abbott Vascular
- FDA Inspection 1226798 - 2023-12-08
- FDA Inspection 1113177 - 2019-10-24
- FDA Inspection 1109808 - 2018-10-26
- FDA Inspection 1043550 - 2017-09-14
- FDA Inspection 951125 - 2015-12-10
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