FDA Inspection
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA Inspection, Sep 25, 2009
Record Details
This FDA Inspection record concerns Fresenius Kabi USA, LLC, with an inspection on September 25, 2009, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fresenius Kabi USA, LLC
- Inspection Date
- September 25, 2009
- Product Type
- Drugs
View Company Profile
ID · e03f958e-b544-464c-a540-5cdc06ba8cf9
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 606967
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
2- 21 CFR 211.25(a)GMP Training Frequency
- 21 CFR 211.22(d)Procedures not in writing, fully followed
Full citation text and observation details available on the Dashboard.
Other FDA inspections of Fresenius Kabi USA, LLC
6| Date | Classification | Office | Project area |
|---|---|---|---|
| August 27, 2024 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| November 25, 2019 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| April 14, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| October 6, 2014 | NAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
| May 4, 2012 | VAI | Center for Drug Evaluation and Research | Bioresearch Monitoring |
Other documents for Fresenius Kabi USA, LLC
- FDA Inspection 1231341 - 2024-08-27
- FDA Inspection 1113433 - 2019-11-25
- FDA Inspection 1019250 - 2017-04-14
- FDA Inspection 897983 - 2014-10-06
- FDA Inspection 783661 - 2012-05-04
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.