FDA Inspection 906221 — Kryolan GmbH
The FDA completed an inspection of Kryolan GmbH on Nov 14, 2014 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). 7 citations were issued during this inspection. Product area: Drugs.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 14, 2014
- Fiscal Year
- 2015
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Berlin (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1274 | 21 CFR 211.68(a) | Calibration/Inspection/Checking not done |
| 1361 | 21 CFR 211.100(a) | Absence of Written Procedures |
| 1626 | 21 CFR 211.130 | Procedures are written, and followed |
| 1787 | 21 CFR 211.80(a) | Procedures To Be in Writing |
| 1810 | 21 CFR 211.160(a) | Lab controls established, including changes |
| 4352 | 21 CFR 211.160(b)(4) | Calibration - at intervals, written program, remedial action |
| 9001 | 21 CFR 211.22(a) | Lack of quality control unit |