FDA Inspection
Covidien, LLCCovidien, LLC – FDA Inspection, Jun 15, 2010
Record Details
This FDA Inspection record concerns Covidien, LLC, with an inspection on June 15, 2010, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Covidien, LLC
- Inspection Date
- June 15, 2010
- Product Type
- Devices
View Company Profile
ID · fccf1fc3-dce5-4335-81ab-748307d2e944
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 668848
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 21 CFR 803.50(a)(2)Individual Report of Malfunction
- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 803.50(b)(3)Conducting an Investigation
- 21 CFR 820.70(c)Environmental control Lack of or inadequate procedures
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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