FDA Inspection 917840 — Klosterfrau Berlin GmbH
The FDA completed an inspection of Klosterfrau Berlin GmbH on Feb 13, 2015 in Berlin. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 10 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 13, 2015
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Berlin (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1162 | 21 CFR 211.28(a) | Protective Apparel Not Worn |
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |
| 2009 | 21 CFR 211.188 | Prepared for each batch, include complete information |
| 2419 | 21 CFR 211.198(a) | Complaint Handling Procedure |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |
| 3613 | 21 CFR 211.160(b)(4) | Establishment of calibration procedures |
| 4302 | 21 CFR 211.56(b) | Written sanitation procedures not followed |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |