Drug factory · FDA FEI 3008310003
SOFIE Co. dba SOFIE
8614 NW 107th Terrace, Kansas City, MO, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 3, 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 2013: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Florbetaben F-18 | Makes it | Lantheus Biosciences Ltd., a Lantheus company | 54828-001 |
| Fludeoxyglucose F-18 | Makes it | SOFIE Co. dba SOFIE | 49609-101 |
| Fluoride Ion F-18 | Makes it | SOFIE Co. dba SOFIE | 49609-102 |
| Flurpiridaz F-18 | Makes it | GE Healthcare Inc. | 0407-8787 |
| Piflufolastat F-18 | Makes it | Progenics Pharmaceuticals, Inc. | 71258-022 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 3, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jan 22, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 15, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Jul 12, 2013 | 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.
Sep 3, 2025 inspection
- Adequate controls (general) 21 CFR 212.50
Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity.
Jan 15, 2016 inspection
- Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures.
Registered with FDA for: positron emission tomography drug production.