FDA Inspection
Klosterfrau Berlin GmbHKlosterfrau Berlin GmbH – FDA Inspection, Jun 7, 2018
Record Details
This FDA Inspection record concerns Klosterfrau Berlin GmbH, with an inspection on June 7, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.
- People
- Christopher R. Czajka (FDA Associated Person)
- Vioela Respress (Issuing Officer)
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ID · b9d3c27c-f2bd-427d-b5c9-d2dc12e959e1
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1056286
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 211.113(b)Validation lacking for sterile drug products
- 21 CFR 211.25(c)Inadequate number of personnel
- 21 CFR 211.22(d)Procedures not in writing, fully followed
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Other FDA inspections of Klosterfrau Berlin GmbH
3| Date | Classification | Office | Project area |
|---|---|---|---|
| September 2, 2022 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 13, 2015 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 13, 2013 | VAI | Center for Food Safety and Applied Nutrition | Food Composition, Standards, Labeling and Econ |
Other documents for Klosterfrau Berlin GmbH
- FDA Inspection 1204454 - 2022-09-02
- FDA Inspection 917840 - 2015-02-13
- FDA Inspection 818016 - 2013-02-13
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