FDA Inspection 1283146 — Mayo Clinic PET Radiochemistry Facility
The FDA completed an inspection of Mayo Clinic PET Radiochemistry Facility on September 24, 2025 in Rochester, MN. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- September 24, 2025
- Fiscal Year
- 2025
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Rochester, MN (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17812 | 21 CFR 212.50 | Adequate controls (general) |