Drug factory · FDA FEI 3008769593
Petnet Solutions, Inc.
2231 4TH AVE S, Birmingham, AL, United States
Problems found, fixed voluntarily at FDA's last inspection, Mar 19, 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 2012: 2 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Piflufolastat F-18 | Makes it | Progenics Pharmaceuticals, Inc. | 71258-022 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 19, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Apr 21, 2016 | No problems found | Drug Quality Assurance | — |
| Jul 18, 2012 | 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.
Mar 19, 2026 inspection
- Testing procedures 21 CFR 212.60(a)
Each laboratory used to conduct testing of finished PET drug products does not follow written procedures for the conduct of each test.
Registered with FDA for: positron emission tomography drug production.