FDA Inspection 980031 — Southern Tissue Center
The FDA completed an inspection of Southern Tissue Center on Jun 3, 2016 in Birmingham, 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 3, 2016
- Fiscal Year
- 2016
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Birmingham, AL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12356 | 21 CFR 1271.195(a) | Adequate control, proper conditions |
| 12399 | 21 CFR 1271.230(a) | Process validation procedures |
| 12401 | 21 CFR 1271.230(b) | Reduced risk representation |
| 12408 | 21 CFR 1271.250(c) | All labeling requirements met |