Drug factory · FDA FEI 3009027673
Barbara Ann Karmanos Cancer Hospital
3901 Beaubien St, Detroit, MI, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 19, 2025.
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 2013: 0 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fludeoxyglucose F-18 | Makes it, tests it, packages it and labels it | Barbara Ann Karmanos Cancer Hospital | 78714-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 19, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Feb 4, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Nov 20, 2013 | 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 19, 2025 inspection
- Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and 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. - When 30 hour rule is exceeded 21 CFR 212.70(e)
A sample for sterility testing was held longer than 30 hours, but you did not demonstrate that the longer period did not adversely affect the sample and that the test results obtained were equivalent to test results that would have been obtained if the test had been started within the 30 hour period.
Feb 4, 2019 inspection
- Written QA procedures established, followed 21 CFR 212.20(e)
You did not establish and follow written quality assurance procedures. - Testing procedures 21 CFR 212.60(a)
Each laboratory used to conduct testing of finished PET drug products does not follow written procedures for the conduct of each test and for the documentation of the results.
Registered with FDA for: analysis; label; pack; positron emission tomography drug production.