FDA Inspection
Covidien, LLCCovidien, LLC – FDA Inspection, Sep 22, 2017
Record Details
This FDA Inspection record concerns Covidien, LLC, with an inspection on September 22, 2017, issued by the Center for Devices and Radiological Health, covering devices.
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ID · 9f03a8cd-678a-473a-ad48-01338fcb14ca
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1026123
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.184DHR content
- 21 CFR 820.75(a)Lack of or inadequate process validation
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Other FDA inspections of Covidien, LLC
2| Date | Classification | Office | Project area |
|---|---|---|---|
| October 17, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| February 26, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Covidien, LLC
- FDA Inspection 803358 - 2012-10-17
- FDA Inspection 648649 - 2010-02-26
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