Drug factory · FDA FEI 3005334016
Northland Nuclear Medicine, LLC
1815 Michigan Ave, Bismarck, ND, United States
Serious problems, FDA action at FDA's last inspection, May 29, 2026.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
2 drug inspections on record since 2023: 0 with no problems, 0 with problems fixed voluntarily, 2 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fludeoxyglucose F-18 | Makes it | Northland Nuclear Medicine | 72634-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 29, 2026 | Serious problems, FDA action | Drug Quality Assurance | 3 |
| Jul 13, 2023 | Serious problems, FDA action | Drug Quality Assurance | 3 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 29, 2026 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 take appropriate corrective actions when necessary. - Orderly handling, prevention of mix-ups, prevention of contamination 21 CFR 212.30(a)
Your facilities are not adequate to ensure 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. - Suitable for intended use 21 CFR 212.40(a)
Your written procedures are not adequate to ensure that the components are suitable for their intended use.
Jul 13, 2023 inspection
- Equipment procedures 21 CFR 212.30(b)
You did not implement procedures to ensure that all equipment is cleaned 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. - Action limits on radiochemical yield 21 CFR 212.50(b)(6)
Your master production and control records did not include a statement of action limits on radiochemical yield.
Registered with FDA for: positron emission tomography drug production.