Drug factory · FDA FEI 3008910148
Petnet Solutions, Inc.
6140 BRISTOL PKWY, Culver City, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jun 20, 2025.
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: 0 with no problems, 4 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 |
|---|---|---|---|
| Jun 20, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 31, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 31, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Aug 29, 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.
May 31, 2016 inspection
- Electronic records 21 CFR 11
Electronic records are used, but they do not meet system access limitation and audit trail requirements to ensure that they are trustworthy, reliable and generally equivalent to paper records. - Specifications and processes 21 CFR 212.20(c)
You did not approve or reject, before implementation, initial procedures to ensure that they would maintain the identity, strength, quality and purity of a PET drug. - Documenting procedures 21 CFR 212.60(f)
You did not document the calibration of laboratory equipment.
Registered with FDA for: positron emission tomography drug production.