FDA Inspection 1326754 — Mayo Clinic PET Radiochemistry Facility
The FDA completed an inspection of Mayo Clinic PET Radiochemistry Facility on Jul 17, 2026 in Jacksonville, FL. 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: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 17, 2026
- Fiscal Year
- 2026
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Jacksonville, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 17778 | 21 CFR 212.40(c) | Use of reliable suppliers |
| 17822 | 21 CFR 212.50(b)(7) | Complete instructions, procedures, specs |
| 17851 | 21 CFR 212.60(c) | Analytical methods |
| 21376 | 21 CFR 212.30(a) | Orderly handling, prevention of mix-ups, prevention of contamination |