Drug factory · FDA FEI 3008302967
SOFIE Co. dba SOFIE
136 Commerce Way, Sanford, FL, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 22, 2024.
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 2014: 0 with no problems, 2 with problems fixed voluntarily, 2 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 | Aphelion LLC, Progenics Pharmaceuticals, Inc. | 85347-001, 71258-022 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 22, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Sep 22, 2021 | Serious problems, FDA action | Drug Quality Assurance | — |
| Apr 12, 2019 | Serious problems, FDA action | Drug Quality Assurance | 3 |
| Aug 5, 2014 | 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 22, 2024 inspection
- Personnel not qualified 21 CFR 212.10
You lack personnel with the necessary training and experience to perform their assigned functions. - 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.
Apr 12, 2019 inspection
- Written complaint procedures 21 CFR 212.100(a)
You have not followed written procedures for the receipt and handling of all complaints concerning the quality or purity of, or possible adverse reactions to, a PET drug product. - 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. - Analytical methods 21 CFR 212.60(c)
Your laboratory analytical methods are not sufficiently accurate and sufficiently reproducible.
Registered with FDA for: positron emission tomography drug production.