Drug factory · FDA FEI 3003932395
SOFIE Co. dba SOFIE
8285 El Rio Suite 160, Houston, TX, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 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 |
| 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 |
|---|---|---|---|
| Oct 28, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 4 |
| Jan 4, 2017 | No problems found | Drug Quality Assurance | — |
| May 6, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 27, 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.
Oct 28, 2025 inspection
- Personnel not qualified 21 CFR 212.10
You lack personnel with the necessary education, background, training and experience to perform their assigned functions. - 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 conduct an investigation and take appropriate corrective actions when necessary. - 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. - Adequate controls (general) 21 CFR 212.50
Your firm lacks adequate production and process controls to ensure the consistent production of a PET drug that meets the applicable standards of identity, strength, quality and purity.
Registered with FDA for: positron emission tomography drug production.