FDA Inspection 1050669 — Octapharma Plasma Inc
The FDA completed an inspection of Octapharma Plasma Inc on May 4, 2018 in Hazelwood, MO. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- May 4, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Hazelwood, MO (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 338 | 21 CFR 640.65(b)(2)(i) | Physician review of four month sample |
| 368 | 21 CFR 640.72(d) | Donor reaction |