Drug factory · FDA FEI 3009856083
Petnet Solutions, Inc.
2921 STOCKTON BLVD STE 1700, Sacramento, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Dec 4, 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 2013: 3 with no problems, 1 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 |
|---|---|---|---|
| Dec 4, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Nov 6, 2020 | No problems found | Drug Quality Assurance | — |
| Aug 18, 2016 | No problems found | Drug Quality Assurance | — |
| Oct 11, 2013 | 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.
Dec 4, 2025 inspection
- Equipment procedures 21 CFR 212.30(b)
You did not implement procedures and document your activities in accordance with your procedures to ensure that all equipment is cleaned and suitable for its intended purposes 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. - Equipment 21 CFR 212.60(e)
All equipment used to perform the testing is not suitable for its intended purposes and capable of producing valid results.
Registered with FDA for: positron emission tomography drug production.