Company
United StatesCovidien, LLC, Santa Clara, CA – FDA Inspections
Inspection records and compliance data for Covidien, LLC in Santa Clara, California. 10 FDA inspections on record, 1 Form 483, last inspected May 10, 2017.
Company Profile
This profile covers Covidien, LLC based in Santa Clara, California, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 0
- VAI
- 4
- NAI
- 5
- Unclassified
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected February 23, 2009. Last inspected May 10, 2017.
Most cited issue areas
- Individual Report of Malfunction3 inspections
- Conducting an Investigation1 inspection
- Design input - documentation1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| May 10, 2017 | Not classified | Medical Devices & Rad Health | 1031445 |
| September 20, 2016 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 984992 |
| June 3, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 932211 |
| May 16, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 834276 |
| May 17, 2012 | VAI | Medical Devices & Rad Health · Compliance: Devices | 782057 |
| December 5, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 756849 |
| September 2, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 681613 |
| June 15, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 668848 |
| January 25, 2010 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 642872 |
| February 23, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 566801 |
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, LLC
FEI Number
3004904811
Address
3062 Bunker Hill Ln, Santa Clara, California 95054, United States
Country
United States
ID: 0787a7fa-505a-419e-afe8-8c492f5cf1d8