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FDA Inspection
•Covidien•November 18, 2008

Covidien – FDA Inspection, Nov 18, 2008

Record Details

This FDA Inspection record concerns Covidien, with an inspection on November 18, 2008, issued by the Center for Devices and Radiological Health, covering devices.

Company
Covidien
Inspection Date
November 18, 2008
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 7c9252e1-da39-4679-bb43-15ef6f882250

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
547271
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

1
  1. 21 CFR 820.30(f)Design verification procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Covidien

3
DateClassificationOfficeProject area
December 16, 2013NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
March 14, 2013NAICenter for Devices and Radiological HealthCompliance: Devices
June 16, 2011NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Covidien
  • FDA Inspection 861417 - 2013-12-16
  • FDA Inspection 822909 - 2013-03-14
  • FDA Inspection 731620 - 2011-06-16

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