FDA Inspection 1216178 — Burgwedel Biotech GmbH
The FDA completed an inspection of Burgwedel Biotech GmbH on Aug 29, 2023 in Burgwedel. 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). 1 citation was issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 29, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Vaccines and Allergenic Products
- Location
- Burgwedel (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3602 | 21 CFR 211.160(a) | Deviations from laboratory control requirements |