FDA Inspection 1218250 — Octapharma AB
The FDA completed an inspection of Octapharma AB on Sep 19, 2023 in Stockholm. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Sep 19, 2023
- Fiscal Year
- 2023
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Stockholm (Sweden)
Citations
| ID | CFR | Description |
|---|---|---|
| 1213 | 21 CFR 211.67(a) | Cleaning / Sanitizing / Maintenance |
| 3572 | 21 CFR 211.100(b) | Procedure Deviations Recorded and Justified |
| 3583 | 21 CFR 211.110(a) | Written in-process control procedures |