Drug factory · FDA FEI 3008912060
Petnet Solutions, Inc.
14 WALKER WAY STE 3, Albany, NY, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 9, 2026.
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 2012: 1 with no problems, 3 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 |
|---|---|---|---|
| Jan 9, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Jul 9, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Aug 5, 2016 | No problems found | Drug Quality Assurance | — |
| Aug 17, 2012 | 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.
Jan 9, 2026 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 determine the need for an investigation, conduct an investigation and take appropriate corrective actions when necessary. - Analytical methods 21 CFR 212.60(c)
Your laboratory analytical methods are not suitable for their intended use, sufficiently sensitive, sufficiently specific, sufficiently accurate and sufficiently reproducible.
Jul 9, 2021 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. - 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. - Analytical methods 21 CFR 212.60(c)
Your laboratory analytical methods are not sufficiently accurate and sufficiently reproducible.
Registered with FDA for: positron emission tomography drug production.