FDA Inspection 660784 — American Red Cross Blood Services Great Lakes Region
The FDA completed an inspection of American Red Cross Blood Services Great Lakes Region on April 27, 2010 in Lansing, MI. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- April 27, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Lansing, MI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12202 | 21 CFR 606.170(a) | Adverse Reaction - Investigations |
| 98 | 21 CFR 606.100(c) | Thorough investigations |