Drug factory · FDA FEI 3008302705
N-Molecular, Inc. dba SOFIE
25 Walker Way, Suite 3D, Colonie, NY, United States
No problems found at FDA's last inspection, Feb 5, 2026.
No Action Indicated: inspectors found no objectionable conditions.
4 drug inspections on record since 2011: 1 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Fludeoxyglucose F-18 | Makes it | SOFIE Co. dba SOFIE | 49609-101 |
| Piflufolastat F-18 | Makes it | Progenics Pharmaceuticals, Inc. | 71258-022 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Feb 5, 2026 | No problems found | Drug Quality Assurance | — |
| Jan 13, 2020 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Feb 12, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 14, 2011 | 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.
Jan 13, 2020 inspection
- Personnel not qualified 21 CFR 212.10
You lack personnel with the necessary training to perform their assigned functions. - Compendial test procedure 21 CFR 212.70(b)
You used an established compendial test procedure in a specification, but you did not first verify that the test works under the conditions of actual use. - Correction of problems 21 CFR 212.71(c)
You did not take appropriate action to correct any identified problems to prevent recurrence of a nonconforming product or other quality problem.
Registered with FDA for: positron emission tomography drug production.