FDA Inspection
Klosterfrau Berlin GmbHKlosterfrau Berlin GmbH – FDA Inspection, Feb 13, 2015
Record Details
This FDA Inspection record concerns Klosterfrau Berlin GmbH, with an inspection on February 13, 2015, issued by the Center for Drug Evaluation and Research, covering drugs.
- Company
- Klosterfrau Berlin GmbH
- Inspection Date
- February 13, 2015
- Product Type
- Drugs
View Company Profile
ID · 8bd49ca0-1f42-4e08-9a6e-45aabc47a64c
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 917840
- FDA center
- Human Drugs
- Project area
- Drug Quality Assurance
FDA Citations
10- 21 CFR 211.188Prepared for each batch, include complete information
- 21 CFR 211.160(a)Following/documenting laboratory controls
- 21 CFR 211.194(a)(8)Second person sign off
- 21 CFR 211.160(b)(4)Establishment of calibration procedures
- 21 CFR 211.198(a)Complaint Handling Procedure
- 21 CFR 211.113(b)Procedures for sterile drug products
- 21 CFR 211.28(a)Protective Apparel Not Worn
- 21 CFR 211.68(a)Calibration/Inspection/Checking not done
- 21 CFR 211.110(a)Written in-process control procedures
- 21 CFR 211.56(b)Written sanitation procedures not followed
Full citation text and observation details available on the Dashboard.
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 |
| June 7, 2018 | 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 1056286 - 2018-06-07
- FDA Inspection 818016 - 2013-02-13
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.