Drug factory · FDA FEI 3007844012
Petnet Solutions, Inc.
1350 MANUFACTURING ST STE 105, Dallas, TX, United States
No problems found at FDA's last inspection, Dec 11, 2025.
No Action Indicated: inspectors found no objectionable conditions.
2 drug inspections on record since 2017: 1 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 |
| 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 |
|---|---|---|---|
| Dec 11, 2025 | No problems found | Drug Quality Assurance | — |
| May 22, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
May 22, 2017 inspection
- Prevention of contamination 21 CFR 212.30(a)
Your facilities are not adequate to ensure the prevention of contamination of equipment by environmental conditions that could reasonably be expected to have an adverse effect on product quality. - Equipment not clean 21 CFR 212.30(b)
You did not implement procedures to ensure that all your equipment is clean.
Registered with FDA for: positron emission tomography drug production.