FDA Inspection
Covidien, LLCCovidien, LLC – FDA Inspection, Feb 23, 2009
Record Details
This FDA Inspection record concerns Covidien, LLC, with an inspection on February 23, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Covidien, LLC
- Inspection Date
- February 23, 2009
- Product Type
- Devices
View Company Profile
ID · fd3a7cd5-f0e0-44cb-886b-98077f677e69
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 566801
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
9- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 820.30(c)Design input - documentation
- 21 CFR 820.25(b)Training
- 21 CFR 820.20Management responsibility
- 21 CFR 820.100(a)(3)Identification of actions needed
- 21 CFR 820.25(b)Training - Lack of or inadequate procedures
- 21 CFR 820.160(a)Expired or deteriorated devices
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.30(g)Design validation - simulated testing
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Covidien, LLC
9| Date | Classification | Office | Project area |
|---|---|---|---|
| May 10, 2017 | Not classified | San Francisco District Office | |
| September 20, 2016 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| June 3, 2015 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 16, 2013 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| May 17, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Covidien, LLC
- FDA Inspection 1031445 - 2017-05-10
- FDA Inspection 984992 - 2016-09-20
- FDA Inspection 932211 - 2015-06-03
- FDA Inspection 834276 - 2013-05-16
- FDA Inspection 782057 - 2012-05-17
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