FDA Inspection
Covidien LPCovidien LP – FDA Inspection, Aug 15, 2013
Record Details
This FDA Inspection record concerns Covidien LP, with an inspection on August 15, 2013, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Covidien LP
- Inspection Date
- August 15, 2013
- Product Type
- Devices
View Company Profile
ID · a65b1270-3133-4887-a0d1-e3fdc4324bb1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 844859
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.198(b)Rationale documented for no investigation
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Covidien LP
9| Date | Classification | Office | Project area |
|---|---|---|---|
| November 18, 2022 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| May 19, 2017 | Not classified | New England District Office | |
| May 17, 2017 | Not classified | New England District Office | |
| July 20, 2012 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 9, 2012 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Covidien LP
- FDA Inspection 1191674 - 2022-11-18
- FDA Inspection 1029477 - 2017-05-19
- FDA Inspection 1034600 - 2017-05-17
- FDA Inspection 792561 - 2012-07-20
- FDA Inspection 778312 - 2012-04-09
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