FDA Inspection 1264963 — Lifesouth Community Blood Centers Inc. - East Alabama Region
The FDA completed an inspection of Lifesouth Community Blood Centers Inc. - East Alabama Region on March 26, 2025 in Opelika, AL. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- March 26, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Opelika, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 65 | 21 CFR 606.65(c) | Testing of representative samples of reagent lots |
| 67 | 21 CFR 606.65(e) | Following manufacturer's instructions |
| 93 | 21 CFR 606.100(b)(14) | QC procedures for supplies and reagents |
| 98 | 21 CFR 606.100(c) | Thorough investigations |