FDA Inspection 793025 — Octapharma Plasma, Inc.
The FDA completed an inspection of Octapharma Plasma, Inc. on Jul 24, 2012 in Lynchburg, VA. 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
- Jul 24, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lynchburg, VA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 333 | 21 CFR 640.64(e) | Prevention of contamination |
| 376 | 21 CFR 640.120 | Alternative procedures |
| 98 | 21 CFR 606.100(c) | Thorough investigations |