FDA Inspection
Covidien LPCovidien LP – FDA Inspection, Jun 18, 2014
Record Details
This FDA Inspection record concerns Covidien LP, with an inspection on June 18, 2014, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Covidien LP
- Inspection Date
- June 18, 2014
- Product Type
- Devices
View Company Profile
ID · 2553f016-3f7a-433f-a92b-3f59b3bd2ee4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 885534
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
4- 21 CFR 820.198(c)Investigation of device failures
- 21 CFR 820.198(d)Evaluation, timeliness, identification
- 21 CFR 820.75(a)Documentation
- 21 CFR 820.75(b)(2)Documentation of validated process performance
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Covidien LP
2| Date | Classification | Office | Project area |
|---|---|---|---|
| August 23, 2012 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 6, 2009 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Covidien LP
- FDA Inspection 800431 - 2012-08-23
- FDA Inspection 620490 - 2009-08-06
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.