FDA Inspection
Abbott Vascular, Inc.Abbott Vascular, Inc. – FDA Inspection, Aug 30, 2010
Record Details
This FDA Inspection record concerns Abbott Vascular, Inc., with an inspection on August 30, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Abbott Vascular, Inc.
- Inspection Date
- August 30, 2010
- Product Type
- Devices
View Company Profile
ID · d2b288d5-7830-474f-a6b6-58cef37b302c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 671689
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
6- 21 CFR 803.50(b)(1)Reporting Information Reasonably Known
- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
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Other FDA inspections of Abbott Vascular, Inc.
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 14, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| December 1, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Abbott Vascular, Inc.
- FDA Inspection 938243 - 2015-08-14
- FDA Inspection 755405 - 2011-12-01
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