Company
SwedenFresenius Kabi AB, Uppsala, Sweden – FDA Inspections
Inspection records and compliance data for Fresenius Kabi AB in Uppsala. 8 FDA inspections on record, 1 Form 483, last inspected April 21, 2023.
Company Profile
This profile covers Fresenius Kabi AB based in Uppsala, Sweden.
FDA Inspection History
- FDA inspections
- 8
- OAI
- 0
- VAI
- 7
- NAI
- 1
- Form 483s
- 1
- Warning letters
- 0
First inspected September 30, 2010. Last inspected April 21, 2023.
Most cited issue areas
- Approval and review of procedures1 inspection
- Cleaning/maintenance records not kept1 inspection
- Cleaning / Sanitizing / Maintenance1 inspection
FDA inspections (8)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| April 21, 2023 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 1238177 |
| October 15, 2020 | VAI | Human Drugs · Drug Quality Assurance | 1155467 |
| October 16, 2018 | VAI | Human Drugs · Drug Quality Assurance | 1099421 |
| February 7, 2017 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 1005000 |
| March 20, 2015 | VAI | Medical Devices & Rad Health · Bioresearch Monitoring | 925969 |
| April 11, 2014 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 876533 |
| September 25, 2012 | NAI | Human Drugs · Drug Quality Assurance | 802513 |
| September 30, 2010 | VAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 695691 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Companies with similar regulatory profiles, compliance history, and operations.
Company Information
Name
Fresenius Kabi AB
FEI Number
3002631703
Address
Rapsgatan 7, Uppsala, Sweden
Country
Sweden
ID: 95acd39b-72be-48a9-aa55-38713a33c8cc