Company
United StatesCovidien, Ponce, PR – FDA Inspections
Inspection records and compliance data for Covidien in Ponce, Puerto Rico. 4 FDA inspections on record, last inspected September 19, 2018.
Company Profile
This profile covers Covidien based in Ponce, Puerto Rico, United States.
FDA Inspection History
- FDA inspections
- 4
- OAI
- 0
- VAI
- 1
- NAI
- 3
- Form 483s
- 0
- Warning letters
- 0
First inspected March 3, 2010. Last inspected September 19, 2018.
Most cited issue areas
- Individual Report of Malfunction1 inspection
- Lack of or inadequate procedures1 inspection
FDA inspections (4)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| September 19, 2018 | NAI | Medical Devices & Rad Health · Radiation Control and Health Safety Act | 1073469 |
| October 31, 2016 | NAI | Medical Devices & Rad Health · Compliance: Devices | 991996 |
| August 27, 2014 | VAI | Medical Devices & Rad Health · Compliance: Devices | 892814 |
| March 3, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 649689 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
Related Companies (10)
Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Covidien
FEI Number
2647580
Address
201 Sabanetas Industrial Park, Building 911-67, Ponce, Puerto Rico 00716, United States
Country
United States
ID: d00512e5-dda9-4409-9e5d-600eb5667563