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FDA Inspection
•Abbott Vascular•March 12, 2012

Abbott Vascular – FDA Inspection, Mar 12, 2012

Record Details

This FDA Inspection record concerns Abbott Vascular, with an inspection on March 12, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company
Abbott Vascular
Inspection Date
March 12, 2012
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 82bf44bf-efee-4758-9342-fc4c655c98b0

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
775601
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

3
  1. 21 CFR 820.100(b)Documentation
  2. 21 CFR 820.90(b)(2)Product rework documentation, DHR {see also 820.184}
  3. 21 CFR 806.20(a)Records not kept

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Abbott Vascular

1
DateClassificationOfficeProject area
August 16, 2017Not classifiedSan Juan District Office
Other documents for Abbott Vascular
  • FDA Inspection 1040816 - 2017-08-16

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