Drug factory · FDA FEI 3009119769
Mayo Clinic PET Radiochemistry Facility
200 1st St SW, Rochester, MN, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 24, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2012: 0 with no problems, 5 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 |
|---|---|---|---|
| Sep 24, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Dec 4, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 3, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 11, 2014 | Problems found, fixed voluntarily | Bioresearch Monitoring | 2 |
| Mar 15, 2012 | 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.
Sep 24, 2025 inspection
- 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.
Jul 11, 2014 inspection
- Failure to develop written procedures 21 CFR 314.80(b)
Written procedures have not been developed for the surveillance, receipt, evaluation, and reporting to FDA of post marketing adverse drug experiences. - Interval 21 CFR 314.80(c)(2)
Periodic reports of non-alert adverse drug experiences have not been submitted quarterly for an application which was approved less than three years ago.
Registered with FDA for: manufacture.