Drug factory · FDA FEI 3008685981
N-Molecular Inc. dba SOFIE
7650 First Place, Bldg B, Suite A, Oakwood Village, OH, United States
No problems found at FDA's last inspection, Jun 6, 2025.
No Action Indicated: inspectors found no objectionable conditions.
3 drug inspections on record since 2014: 2 with no problems, 1 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 |
|---|---|---|---|
| Jun 6, 2025 | No problems found | Drug Quality Assurance | — |
| May 2, 2019 | No problems found | Drug Quality Assurance | — |
| Jan 31, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: positron emission tomography drug production.