FDA Inspection
CovidienCovidien – FDA Inspection, Apr 28, 2022
Record Details
This FDA Inspection record concerns Covidien, with an inspection on April 28, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Covidien
- Inspection Date
- April 28, 2022
- Product Type
- Devices
View Company Profile
ID · 3438572c-b6b6-4df1-a18b-e3fa60faff2c
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1169814
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
2- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.80(a)Lack of or inadequate procedures - Acceptance activities
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Covidien
3| Date | Classification | Office | Project area |
|---|---|---|---|
| August 9, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 22, 2014 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 17, 2011 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
Other documents for Covidien
- FDA Inspection 1036260 - 2017-08-09
- FDA Inspection 900524 - 2014-08-22
- FDA Inspection 739627 - 2011-08-17
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.