FDA Inspection 930212 — Octapharma Plasma, Inc.
The FDA completed an inspection of Octapharma Plasma, Inc. on May 15, 2015 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
- May 15, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- North Charleston, SC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 9234 | 21 CFR 630.40(c) | Notification w/in 8 weeks |