FDA Inspection 701472 — Mayo Clinic Rochester
The FDA completed an inspection of Mayo Clinic Rochester on Dec 10, 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 10, 2010
- Fiscal Year
- 2011
- Product Type
- Biologics
- Project Area
- Human Cellular, Tissue, and Gene Therapies
- Location
- Rochester, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 12282 | 21 CFR 1271.75(d) | Donors with risks not determined ineligible |
| 12379 | 21 CFR 1271.210(d)(1) | Receipt documentation elements |
| 12381 | 21 CFR 1271.210(d)(2) | Verification elements |
| 12412 | 21 CFR 1271.260(b) | Storage temperatures appropriate |