FDA Inspection 1253986 — Octapharma Dessau GmbH
The FDA completed an inspection of Octapharma Dessau GmbH on Nov 8, 2024 in Dessau-Roslau. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 8, 2024
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Dessau-Roslau (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1098 | 21 CFR 211.22(c) | Approve or reject procedures or specs |
| 2012 | 21 CFR 211.188(b) | Batch production and Batch Control Record Requirements |
| 4402 | 21 CFR 211.192 | Written record of investigation incomplete |
| 9086 | 21 CFR 600.14(a)(1) | Who must report - manufacturer |