Drug factory · FDA FEI 3008488707
Petnet Solutions, Inc.
9012 CODY ST, Overland Park, KS, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 5, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2011: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Flotufolastat F-18 | Makes it | Blue Earth Diagnostics | 69932-002 |
| Fluciclovine F-18 | Makes it | Blue Earth Diagnostics | 69932-001 |
| Piflufolastat F-18 | Makes it | Progenics Pharmaceuticals, Inc. | 71258-022 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 5, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Nov 5, 2019 | No problems found | Drug Quality Assurance | — |
| Apr 1, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 18, 2011 | No problems found | 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 5, 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.
Registered with FDA for: positron emission tomography drug production.