FDA Inspection 753726 — LifeSouth Community Blood Centers Inc - Huntsville Hospital Donor Center
The FDA completed an inspection of LifeSouth Community Blood Centers Inc - Huntsville Hospital Donor Center on Nov 4, 2011 in Huntsville, 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). 7 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 4, 2011
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Huntsville, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 15030 | 21 CFR 606.60(b) | Equipment calibration frequency |
| 154 | 21 CFR 606.160(a)(1) | Concurrent documentation |
| 155 | 21 CFR 606.160(b) | Required records |
| 251 | 21 CFR 640.25(b) | Quality control |
| 253 | 21 CFR 640.25(b)(4) | Corrective action |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |
| 98 | 21 CFR 606.100(c) | Thorough investigations |