Company
United StatesFresenius USA, Inc., Concord, CA – FDA Inspections
Inspection records and compliance data for Fresenius USA, Inc. in Concord, California. 10 FDA inspections on record, last inspected August 27, 2015.
Company Profile
This profile covers Fresenius USA, Inc. based in Concord, California, United States.
FDA Inspection History
- FDA inspections
- 10
- OAI
- 0
- VAI
- 3
- NAI
- 7
- Form 483s
- 0
- Warning letters
- 0
First inspected June 9, 2009. Last inspected August 27, 2015.
Most cited issue areas
- Lack of or inadequate procedures2 inspections
- Design validation- Lack of or inadequate procedures1 inspection
- Lack of or inadequate procedures for distribution1 inspection
FDA inspections (10)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 27, 2015 | NAI | Medical Devices & Rad Health · Compliance: Devices | 940274 |
| January 30, 2014 | NAI | Medical Devices & Rad Health · Compliance: Devices | 864135 |
| March 14, 2013 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 822918 |
| February 22, 2013 | VAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 822364 |
| December 7, 2011 | VAI | Medical Devices & Rad Health · Compliance: Devices | 755564 |
| October 24, 2011 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 748172 |
| November 16, 2010 | VAI | Medical Devices & Rad Health · Compliance: Devices | 697563 |
| October 15, 2010 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 685798 |
| June 16, 2009 | NAI | Medical Devices & Rad Health · Compliance: Devices | 598163 |
| June 9, 2009 | NAI | Medical Devices & Rad Health · Postmarket Assurance: Devices | 588856 |
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
Fresenius USA, Inc.
FEI Number
2937457
Address
4040 Nelson Ave, Concord, California 94520, United States
Country
United States
ID: 3cc6adda-f320-4810-b4a0-0cf6c6321f86