FDA Inspection 758993 — LifeSource-Upper Midwest OPO
The FDA completed an inspection of LifeSource-Upper Midwest OPO on Jan 24, 2012 in Minneapolis, MN. 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). 3 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jan 24, 2012
- Fiscal Year
- 2012
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Minneapolis, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12310 | 21 CFR 1271.160(a) | All core requirements covered in program |
| 12336 | 21 CFR 1271.180(a) | Procedures to meet core CTGP |
| 12436 | 21 CFR 1271.270(a) | Accurate, indelible, legible |