FDA Inspection
Fresenius Kabi ABFresenius Kabi AB – FDA Inspection, Sep 30, 2010
Record Details
This FDA Inspection record concerns Fresenius Kabi AB, with an inspection on September 30, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fresenius Kabi AB
- Inspection Date
- September 30, 2010
- Product Type
- Drugs
View Company Profile
ID · f3cc617d-585c-4b36-aaec-508bb71c4d69
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 695691
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.100(b)Procedure Deviations Recorded and Justified
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.67(c)Cleaning/maintenance records not kept
- 21 CFR 211.100(a)Approval and review of procedures
- 21 CFR 211.100(b)SOPs not followed / documented
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fresenius Kabi AB
7| Date | Classification | Office | Project area |
|---|---|---|---|
| April 21, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 15, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 16, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 7, 2017 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 20, 2015 | VAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
Other documents for Fresenius Kabi AB
- FDA Inspection 1238177 - 2023-04-21
- FDA Inspection 1155467 - 2020-10-15
- FDA Inspection 1099421 - 2018-10-16
- FDA Inspection 1005000 - 2017-02-07
- FDA Inspection 925969 - 2015-03-20
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.