FDA Inspection
Fresenius Kabi Austria GMBHFresenius Kabi Austria GMBH – FDA Inspection, Mar 17, 2017
Record Details
This FDA Inspection record concerns Fresenius Kabi Austria GMBH, with an inspection on March 17, 2017, issued by the Center for Drug Evaluation and Research, covering drugs.
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ID · 0aa4441b-5fcc-442c-b12c-0c89f6e550a1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1005862
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
6- 21 CFR 211.42(c)(10)(iv)Environmental Monitoring System
- 21 CFR 211.67(a)Cleaning / Sanitizing / Maintenance
- 21 CFR 211.160(b)Scientifically sound laboratory controls
- 21 CFR 211.192Investigations of discrepancies, failures
- 21 CFR 211.192No written record of investigation
- 21 CFR 123.9(f)Computerized records
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Other FDA inspections of Fresenius Kabi Austria GMBH
12| Date | Classification | Office | Project area |
|---|---|---|---|
| March 21, 2024 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| March 28, 2023 | Not classified | Office of Inspections and Investigations | |
| October 13, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| January 30, 2020 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| April 19, 2018 | Not classified | Office of Inspections and Investigations |
Other documents for Fresenius Kabi Austria GMBH
- FDA Inspection 1251340 - 2024-03-21
- FDA Inspection 1205334 - 2023-03-28
- FDA Inspection 1207391 - 2022-10-13
- FDA Inspection 1162216 - 2020-01-30
- FDA Inspection 1052462 - 2018-04-19
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