FDA Inspection 1266742 — Lifesouth Community Blood Centers - Montgomery Region
The FDA completed an inspection of Lifesouth Community Blood Centers - Montgomery Region on Apr 14, 2025 in Montgomery, AL. 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). 5 citations were issued during this inspection. Product area: Biologics.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 14, 2025
- Fiscal Year
- 2025
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Montgomery, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 224 | 21 CFR 640.4(f) | Arm preparation |
| 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 |