FDA Inspection 1073907 — Rotop Pharmaka GmbH
The FDA completed an inspection of Rotop Pharmaka GmbH on December 7, 2018 in Dresden. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 7, 2018
- Fiscal Year
- 2019
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dresden (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1133 | 21 CFR 211.25(a) | GMP Training Frequency |
| 3632 | 21 CFR 211.170(b) | Annual visual exams of drug products |
| 4315 | 21 CFR 211.84(d)(2) | Testing Each Component for Conformity with Specs |
| 4406 | 21 CFR 211.194(a)(2) | Suitability of testing methods verified |
| 4413 | 21 CFR 211.194(a)(8) | Second person sign off |