Drug factory · FDA FEI 3005705842
SOFIE Co. dba SOFIE
64 Medical Center Drive Rm B042, Morgantown, WV, United States
Problems found, fixed voluntarily at FDA's last inspection, Aug 28, 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: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ammonia N-13 | Makes it | SOFIE Co. dba SOFIE | 49609-003 |
| 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 |
|---|---|---|---|
| Aug 28, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 18, 2016 | No problems found | Drug Quality Assurance | — |
| Jun 6, 2014 | No problems found | Drug Quality Assurance | — |
| Aug 16, 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.
Aug 28, 2025 inspection
- Equipment procedures 21 CFR 212.30(b)
You did not implement procedures to ensure that all equipment is suitable for its intended purposes and properly installed, maintained, and capable of repeatedly producing valid results 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.
Registered with FDA for: positron emission tomography drug production.