FDA Inspection 598388 — LifeSouth Community Blood Centers, Inc.
The FDA completed an inspection of LifeSouth Community Blood Centers, Inc. on Jun 30, 2009 in Mcdonough, GA. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 30, 2009
- Fiscal Year
- 2009
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Mcdonough, GA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12203 | 21 CFR 606.170(a) | Adverse Reaction- Reports of Investigations |
| 155 | 21 CFR 606.160(b) | Required records |
| 158 | 21 CFR 606.160(e)(1) | Donor deferral record - each location |
| 165 | 21 CFR 606.170(a) | Adverse reaction - Maintenance of Reports |