FDA Inspection 1030852 — Oncotec Pharma Produktion GmbH
The FDA completed an inspection of Oncotec Pharma Produktion GmbH on Nov 7, 2017 in Dessau Rosslau. 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). 2 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 7, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Dessau Rosslau (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1111 | 21 CFR 211.25(a) | Training , Education , Experience overall |
| 1451 | 21 CFR 211.113(b) | Procedures for sterile drug products |