FDA Inspection 1036565 — Octapharma Plasma, Inc.
The FDA completed an inspection of Octapharma Plasma, Inc. on December 29, 2017 in Ypsilanti, MI. 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: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 29, 2017
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Ypsilanti, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 306 | 21 CFR 640.73 | Reporting of fatal donor reactions |