FDA Inspection 1112852 — Mayo Clinic PET Radiochemistry Facility
The FDA completed an inspection of Mayo Clinic PET Radiochemistry Facility on December 12, 2019 in Phoenix, AZ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- December 12, 2019
- Fiscal Year
- 2020
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Phoenix, AZ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17812 | 21 CFR 212.50 | Adequate controls (general) |
| 17851 | 21 CFR 212.60(c) | Analytical methods |
| 21373 | 21 CFR 212.30(b) | Equipment procedures |