FDA Inspection 1050664 — Swedish Orphan Biovitrum AB (Publ)
The FDA completed an inspection of Swedish Orphan Biovitrum AB (Publ) on May 4, 2018 in Stockholm. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 4, 2018
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Stockholm (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 4389 | 21 CFR 211.198(a) | Procedures to be written and followed |