Company
United StatesFresenius Kabi USA, LLC, Lake Zurich, IL – FDA Inspections
Inspection records and compliance data for Fresenius Kabi USA, LLC in Lake Zurich, Illinois. 7 FDA inspections on record, last inspected August 27, 2024.
Company Profile
This profile covers Fresenius Kabi USA, LLC based in Lake Zurich, Illinois, United States.
FDA Inspection History
- FDA inspections
- 7
- OAI
- 0
- VAI
- 2
- NAI
- 5
- Form 483s
- 0
- Warning letters
- 0
First inspected September 25, 2009. Last inspected August 27, 2024.
Most cited issue areas
- GMP Training Frequency1 inspection
- Late submission1 inspection
- Late submission of 15-day report1 inspection
FDA inspections (7)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 27, 2024 | NAI | Human Drugs · Bioresearch Monitoring | 1231341 |
| November 25, 2019 | NAI | Medical Devices & Rad Health · Compliance: Devices | 1113433 |
| April 14, 2017 | NAI | Human Drugs · Drug Quality Assurance | 1019250 |
| October 6, 2014 | NAI | Human Drugs · Bioresearch Monitoring | 897983 |
| May 4, 2012 | VAI | Human Drugs · Bioresearch Monitoring | 783661 |
| January 21, 2010 | NAI | Medical Devices & Rad Health · Compliance: Devices | 640523 |
| September 25, 2009 | VAI | Human Drugs · Drug Quality Assurance | 606967 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
Fresenius Kabi USA, LLC
FEI Number
3002733956
Address
3 Corporate Dr, Lake Zurich, Illinois 60047, United States
Country
United States
ID: b7c42c60-8a6f-4ccf-8db1-03c0263b3887