FDA Inspection
CovidienCovidien – FDA Inspection, Aug 27, 2014
Record Details
This FDA Inspection record concerns Covidien, with an inspection on August 27, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Covidien
- Inspection Date
- August 27, 2014
- Product Type
- Devices
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ID · 2a1a1a34-57e5-48fd-b72f-a8f24d333f0e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 892814
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.100(a)Lack of or inadequate procedures
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Other FDA inspections of Covidien
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 19, 2018 | NAI | Center for Devices and Radiological Health | Radiation Control and Health Safety Act |
| October 31, 2016 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 3, 2010 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Covidien
- FDA Inspection 1073469 - 2018-09-19
- FDA Inspection 991996 - 2016-10-31
- FDA Inspection 649689 - 2010-03-03
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