Drug factory · FDA FEI 3005705951
SOFIE Co. dba SOFIE
110 Clyde Road, Suite 1, Somerset, NJ, United States
Problems found, fixed voluntarily at FDA's last inspection, Jan 20, 2023.
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 2010: 1 with no problems, 3 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 |
| Piflufolastat F-18 | Makes it | Progenics Pharmaceuticals, Inc. | 71258-022 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 20, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 8 |
| Jun 24, 2015 | No problems found | Drug Quality Assurance | — |
| Feb 28, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 14, 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.
Jan 20, 2023 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. - 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 determine the need for an investigation, conduct an investigation and take appropriate corrective actions when necessary. - Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures. - Equipment procedures 21 CFR 212.30(b)
You did not implement procedures to ensure that all equipment is cleaned that could reasonably be expected to adversely affect the identity, strength, quality, or purity of a PET drug, or give erroneous or invalid test results when improperly used or maintained. - 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. - Equipment 21 CFR 212.60(e)
All equipment used to perform the testing is not suitable for its intended purposes and capable of producing valid results. - Before implementing new procedure establish and document accuracy etc. 21 CFR 212.70(b)
You implemented a new test procedure in a specification, but you did not first establish and document the accuracy, sensitivity, specificity and reproducibility of the procedure. - 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.