Drug factory · FDA FEI 3012626823
Mayo Clinic PET Radiochemistry Facility
5861 E Mayo Blvd, Phoenix, AZ, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 31, 2026.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
3 drug inspections on record since 2017: 0 with no problems, 3 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 31, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Dec 12, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| May 11, 2017 | 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 31, 2026 inspection
- Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and follow written quality assurance procedures.
Dec 12, 2019 inspection
- Equipment procedures 21 CFR 212.30(b)
You did not implement procedures and document your activities in accordance with your procedures to ensure that all equipment is cleaned and properly installed, maintained, and capable of repeatedly producing valid results that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained. - Adequate controls (general) 21 CFR 212.50
Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity. - Analytical methods 21 CFR 212.60(c)
Your laboratory analytical methods are not suitable for their intended use.
Registered with FDA for: manufacture; positron emission tomography drug production.