FDA Inspection 679651 — LifeSouth Community Blood Centers, Inc.
The FDA completed an inspection of LifeSouth Community Blood Centers, Inc. on September 10, 2010 in Dunwoody, GA. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 5 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 10, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Dunwoody, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 155 | 21 CFR 606.160(b) | Required records |
| 57 | 21 CFR 606.60(a) | Maintain and clean equipment |
| 9235 | 21 CFR 630.40(c) | Documentation |
| 9243 | 21 CFR 630.40(a) | Notification |
| 98 | 21 CFR 606.100(c) | Thorough investigations |