FDA Inspection 649956 — Mayo Clinic Rochester, Division Of Transfusion Medicine
The FDA completed an inspection of Mayo Clinic Rochester, Division Of Transfusion Medicine on Feb 1, 2010 in Rochester, 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Feb 1, 2010
- Fiscal Year
- 2010
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Rochester, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 160 | 21 CFR 606.160(a)(1) | Person performing, test results, interpretation |
| 76 | 21 CFR 606.100(b) | Establish, maintain and follow manufacturing SOPs |