Drug factory · FDA FEI 3009754344
SOFIE Co. dba SOFIE
2300 N Edward St Ste 100, Decatur, IL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 15, 2026.
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: 3 with no problems, 1 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 | 73410-001 |
| Florbetaben F-18 | Makes it | Lantheus Biosciences Ltd., a Lantheus company | 54828-001 |
| Fludeoxyglucose F-18 | Makes it | SOFIE Co. dba SOFIE | 49609-101, 73410-003 |
| Piflufolastat F-18 | Makes it | Progenics Pharmaceuticals, Inc. | 71258-022 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 15, 2026 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Aug 17, 2016 | No problems found | Drug Quality Assurance | — |
| Dec 5, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 24, 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.
Jan 15, 2026 inspection
- Record quality 21 CFR 212.110(b)
All records including those not stored at your inspected establishment are not stored to prevent deterioration or loss. - Determination need for investigation 21 CFR 212.20(d)
When errors occurred or a production batch or any component of the batch, failed to meet specifications, you did not take appropriate corrective actions when necessary.
Registered with FDA for: positron emission tomography drug production.