FDA Inspection
Covidien LLCCovidien LLC – FDA Inspection, Mar 11, 2016
Record Details
This FDA Inspection record concerns Covidien LLC, with an inspection on March 11, 2016, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Covidien LLC
- Inspection Date
- March 11, 2016
- Product Type
- Devices
View Company Profile
ID · deb62198-e7c5-49b5-b99b-15401c84bcf8
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 967428
- FDA center
- Medical Devices & Rad Health
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 803.50(a)(1)Report of Death or Serious Injury
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
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Other FDA inspections of Covidien LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| December 19, 2014 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
| October 30, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Covidien LLC
- FDA Inspection 907806 - 2014-12-19
- FDA Inspection 902679 - 2014-10-30
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