Drug factory · FDA FEI 3007834280
Petnet Solutions, Inc.
9204 FLORIDA PALM DR, Tampa, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 12, 2026.
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 2014: 1 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 |
| Fluoroestradiol F-18 | Makes it | GE Healthcare Inc. | 72874-001 |
| Piflufolastat F-18 | Makes it | Progenics Pharmaceuticals, Inc. | 71258-022 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 12, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jul 13, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Feb 28, 2014 | 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.
Jun 12, 2026 inspection
- Oversight of production operations 21 CFR 212.20(a)
You did not oversee production operations in a manner to ensure that each PET drug meets the requirements of the FD&C Act as to safety and meets the quality and purity characteristics that it is supposed to have. - 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. - Equipment procedures 21 CFR 212.30(b)
You did not implement procedures to ensure that all equipment is suitable for its intended purposes and properly installed, maintained, and capable of repeatedly producing valid results 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.
Jul 13, 2018 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.
Registered with FDA for: positron emission tomography drug production.