Drug factory · FDA FEI 3005550748
Petnet Solutions, Inc.
1301 22ND AVE S, Nashville, TN, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 23, 2024.
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 2013: 2 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 |
|---|---|---|---|
| Aug 23, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jan 7, 2016 | No problems found | Drug Quality Assurance | — |
| Feb 27, 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.
Aug 23, 2024 inspection
- Contamination, mix-ups and deterioration 21 CFR 212.40(d)
You did not handle and store components in a manner that prevents contamination and ensures that they are and remain suitable for their intended use.
Registered with FDA for: positron emission tomography drug production.