FDA Inspection 588676 — Octapharma Plasma, Inc.
The FDA completed an inspection of Octapharma Plasma, Inc. on May 29, 2009 in Wichita, KS. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- May 29, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Wichita, KS (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 3248 | 21 CFR 640.63(a) | Determining donor suitability |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9044 | 21 CFR 600.10(b) | Personnel capabilities |
| 9317 | 21 CFR 640.65(b)(8) | Timing |