FDA Inspection 760964 — Octapharma Plasma, Inc.
The FDA completed an inspection of Octapharma Plasma, Inc. on Dec 2, 2011 in North Charleston, SC. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 2, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- North Charleston, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3258 | 21 CFR 640.63(d) | Unreliable answers |
| 9225 | 21 CFR 606.171 | Biological product deviation report |