Drug factory · FDA FEI 3014201471
Mayo Clinic PET Radiochemistry Facility
14225 Zumbro Dr, Jacksonville, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 17, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2019: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ammonia N-13 | Makes it | Mayo Clinic | 52670-552 |
| Choline C-11 | Makes it | Mayo Clinic | 52670-556 |
| Fludeoxyglucose F-18 | Makes it | Mayo Clinic | 52670-551 |
| Fluoride Ion F-18 | Makes it | Mayo Clinic | 52670-550 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 17, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Apr 12, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Jul 17, 2026 inspection
- Orderly handling, prevention of mix-ups, prevention of contamination 21 CFR 212.30(a)
Your facilities are not adequate to ensure the orderly handling of materials and equipment, the prevention of mix-ups and the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality. - Use of reliable suppliers 21 CFR 212.40(c)
You did not use a reliable supplier as a source of each lot of component, container and closure. - Complete instructions, procedures, specs 21 CFR 212.50(b)(7)
Your master production and control records did not include complete special notations and precautions to be followed. - Analytical methods 21 CFR 212.60(c)
Your laboratory analytical methods are not sufficiently accurate.
Registered with FDA for: manufacture; positron emission tomography drug production.