Drug factory · FDA FEI 3010166888
Division of Nuclear Medicine PET Radiopharmaceutical Production Program
1301 Catherine Street, 2276 Medical Science Building I, SPC-5610, Ann Arbor, MI, United States
Serious problems, FDA action at FDA's last inspection, Sep 17, 2025.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
3 drug inspections on record since 2014: 0 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fludeoxyglucose F-18 | Makes it | The Regents of the University of Michigan | 76326-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 17, 2025 | Serious problems, FDA action | Drug Quality Assurance | 3 |
| Mar 7, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Feb 21, 2014 | 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 17, 2025 inspection
- Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures. - 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. - Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning bacteriological contamination in a distributed drug product.
Mar 7, 2019 inspection
- Determination need for investigation 21 CFR 212.20(d)
When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not conduct an investigation when necessary. - Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and follow written quality assurance procedures. - Rep.sample - containers/closures 21 CFR 212.40(c)(2)
You did not examine a representative sample of each lot of containers and closures for conformity to written specifications. - Rejection of nonconforming product 21 CFR 212.71(a)
You did not reject the batch of a PET drug product that did not conform to specifications.
Registered with FDA for: positron emission tomography drug production.