Drug factory · FDA FEI 3008460209
Petnet Solutions, Inc.
2525 S DOWNING ST, Denver, CO, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 24, 2026.
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 2010: 2 with no problems, 3 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 |
| Fluoroestradiol F-18 | Makes it | GE Healthcare Inc. | 72874-001 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 24, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Oct 17, 2019 | No problems found | Drug Quality Assurance | — |
| Dec 16, 2015 | No problems found | Drug Quality Assurance | — |
| Jun 26, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 24, 2010 | 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.
Mar 24, 2026 inspection
- Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures.
Registered with FDA for: positron emission tomography drug production.