FDA Inspection 620047 — The Community Blood Center, Inc.
The FDA completed an inspection of The Community Blood Center, Inc. on Oct 14, 2009 in Appleton, WI. 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
- Oct 14, 2009
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Appleton, WI (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 9089 | 21 CFR 600.14(c) | When to report |
| 9238 | 21 CFR 630.40(b)(3) | Results of testing |