Drug factory · FDA FEI 3009015455
Petnet Solutions, Inc.
3601 W 13 MILE RD, Royal Oak, MI, United States
No problems found at FDA's last inspection, Apr 30, 2025.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2013: 2 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 |
| Piflufolastat F-18 | Makes it | Progenics Pharmaceuticals, Inc. | 71258-022 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 30, 2025 | No problems found | Drug Quality Assurance | — |
| Nov 8, 2018 | No problems found | Drug Quality Assurance | — |
| Sep 23, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Feb 14, 2013 | 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.
Sep 23, 2016 inspection
- Analytical methods 21 CFR 212.60(c)
Your laboratory analytical methods are not sufficiently specific and are not accurate.
Registered with FDA for: positron emission tomography drug production.