FDA Inspection
Fresenius Kabi Deutschland GmbHFresenius Kabi Deutschland GmbH – FDA Inspection, Sep 26, 2014
Record Details
This FDA Inspection record concerns Fresenius Kabi Deutschland GmbH, with an inspection on September 26, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.
- Inspection Date
- September 26, 2014
- Product Type
- Drugs
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ID · 56c5998e-7ec1-4c94-adcb-4ab78684b781
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 900868
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
7- 21 CFR 211.42(a)Buildings of Suitable Size, Construction, Location
- 21 CFR 211.46(b)Equipment for Environmental Control
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.84(b)Representative Samples
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.42(b)Product flow through building is inadequate
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Other FDA inspections of Fresenius Kabi Deutschland GmbH
3| Date | Classification | Office | Project area |
|---|---|---|---|
| October 19, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 5, 2019 | Not classified | Office of Inspections and Investigations | |
| April 11, 2018 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Fresenius Kabi Deutschland GmbH
- FDA Inspection 1208229 - 2022-10-19
- FDA Inspection 1103462 - 2019-09-05
- FDA Inspection 1050946 - 2018-04-11
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