Drug factory · FDA FEI 3011121261
Petnet Solutions, Inc.
11100 EUCLID AVE RM S-106A, Cleveland, OH, United States
Problems found, fixed voluntarily at FDA's last inspection, Feb 17, 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 2015: 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 |
|---|---|---|---|
| Feb 17, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Sep 12, 2019 | No problems found | Drug Quality Assurance | — |
| Oct 8, 2015 | 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.
Feb 17, 2026 inspection
- 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 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. - In-process materials controls 21 CFR 212.50(e)
Your process controls did not include control of in-process materials to ensure that the materials are controlled until required tests or other verification activities have been completed or necessary approvals are received and documented. - Instrument specifications 21 CFR 361.1(d)(1)(iv)
The RDRC did not assure that the investigator utilized adequate instrumentation for the detection and measurement of the specific radionuclide.
Registered with FDA for: positron emission tomography drug production.