Drug factory · FDA FEI 3004187716
Klosterfrau Berlin GmbH
Motzener Str. 41, Berlin, Germany
Problems found, fixed voluntarily at FDA's last inspection, Oct 2, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2015: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Glycerin and Hydroxyethyl Cellulose (5500 Mpa.s At 2%) and Water | Makes it, tests it, labels it and sterilizes it | Giskit Pharma B.v. | 73254-310 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 2, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 2, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 7, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Feb 13, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 10 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jun 7, 2018 inspection
- Validation lacking for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process. - Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - Inadequate number of personnel 21 CFR 211.25(c)
The number of qualified personnel is inadequate to perform the processing of each drug product.
Feb 13, 2015 inspection
- Written in-process control procedures 21 CFR 211.110(a)
Written procedures are not established that describe the examinations to be conducted on appropriate samples of in-process materials of each batch. - Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established. - Following/documenting laboratory controls 21 CFR 211.160(a)
Established laboratory control mechanisms are not followed. - Establishment of calibration procedures 21 CFR 211.160(b)(4)
Procedures describing the calibration of instruments, apparatus, gauges and recording devices are deficiently written or followed. - Prepared for each batch, include complete information 21 CFR 211.188
Batch production and control records do not include complete information relating to the production and control of each batch. - Second person sign off 21 CFR 211.194(a)(8)
Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy and completeness. - Complaint Handling Procedure 21 CFR 211.198(a)
Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed. - Protective Apparel Not Worn 21 CFR 211.28(a)
Protective apparel is not worn as necessary to protect drug products from contamination. - Written sanitation procedures not followed 21 CFR 211.56(b)
Written procedures for sanitation are not followed. - Calibration/Inspection/Checking not done 21 CFR 211.68(a)
Routine checking of electronic equipment is not performed according to a written program designed to assure proper performance.
Registered with FDA for: analysis; label; manufacture; pack; sterilize.