FDA Inspection
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA Inspection, May 4, 2012
Record Details
This FDA Inspection record concerns Fresenius Kabi USA, LLC, with an inspection on May 4, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fresenius Kabi USA, LLC
- Inspection Date
- May 4, 2012
- Product Type
- Drugs
View Company Profile
ID · 7f2dca2e-d5ed-4c54-824e-619c1b024613
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 783661
- FDA center
- Human Drugs
- Project area
- Bioresearch Monitoring
FDA Citations
3- 21 CFR 310.305(c)(1)(i)Late submission
- 21 CFR 314.80(c)(1)(i)Late submission of 15-day report
- 21 CFR 314.80(c)(2)Late submission of annual safety reports
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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 |
| January 21, 2010 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
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 640523 - 2010-01-21
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