FDA Inspection 680693 — Grifols Bio Supplies Inc
The FDA completed an inspection of Grifols Bio Supplies Inc on Oct 20, 2010 in Miami, FL. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 9 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Oct 20, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Miami, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 206 | 21 CFR 640.3(a) | Donor suitability determined by unqualified person |
| 208 | 21 CFR 640.3(a)(1) | Donor suitability procedures not followed |
| 31 | 21 CFR 606.20(b) | Qualifications of responsible personnel |
| 32 | 21 CFR 606.20(c) | Exclusion of certain persons |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9234 | 21 CFR 630.40(c) | Notification w/in 8 weeks |
| 9297 | 21 CFR 640.52 | Collection |
| 98 | 21 CFR 606.100(c) | Thorough investigations |