Drug factory · FDA FEI 3004977184
SOFIE Co. dba SOFIE
100 Executive Drive, Suite 4 & 7, Sterling, VA, United States
Problems found, fixed voluntarily at FDA's last inspection, Jul 25, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2010: 1 with no problems, 4 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 |
|---|---|---|---|
| Jul 25, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Dec 3, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Jan 23, 2015 | No problems found | Drug Quality Assurance | — |
| Feb 1, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 11, 2010 | 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.
Jul 25, 2025 inspection
- Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures. - Conform to specs prior to release 21 CFR 212.70(c)
You did not conduct an appropriate laboratory determination to ensure that each batch of a PET drug product conforms to specifications before final release.
Dec 3, 2018 inspection
- Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures. - Orderly handling, prevention of mix-ups, prevention of contamination 21 CFR 212.30(a)
Your facilities are not adequate to ensure the prevention of contamination of equipment or product by substances, personnel, or environmental conditions that could reasonably be expected to have an adverse effect on product quality. - Contamination, chemical or physical change, deterioration 21 CFR 314.81(b)(1)(ii)
An NDA-Field Alert Report was not submitted within three working days of receipt of information concerning significant chemical, physical, or other change or deterioration in a distributed drug product.
Registered with FDA for: positron emission tomography drug production.