FDA Inspection
Fresenius Kabi USA, LLCFresenius Kabi USA, LLC – FDA Inspection, Feb 4, 2016
Record Details
This FDA Inspection record concerns Fresenius Kabi USA, LLC, with an inspection on February 4, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Fresenius Kabi USA, LLC
- Inspection Date
- February 4, 2016
- Product Type
- Drugs
View Company Profile
ID · 6e9fb937-55f5-4054-923c-bc884ae55733
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 962308
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
5- 21 CFR 211.192Quality control unit review of records
- 21 CFR 211.25(a)Training , Education , Experience overall
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 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
15| Date | Classification | Office | Project area |
|---|---|---|---|
| May 14, 2026 | Not classified | New York District Office | Drug Quality Assurance |
| October 13, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| August 30, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
| August 12, 2019 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| June 29, 2018 | Not classified | New York District Office |
Other documents for Fresenius Kabi USA, LLC
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.