Drug factory · FDA FEI 3005693151
N-Molecular, Inc. dba SOFIE
11 Rogers Road, Suite 6, Haverhill, MA, United States
Problems found, fixed voluntarily at FDA's last inspection, Nov 20, 2024.
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 2013: 0 with no problems, 4 with problems fixed voluntarily, 1 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 |
|---|---|---|---|
| Nov 20, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| May 16, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Feb 28, 2018 | Serious problems, FDA action | Drug Quality Assurance | 6 |
| Aug 7, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 11, 2013 | 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.
Nov 20, 2024 inspection
- Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures. - Contact surfaces 21 CFR 212.30(c)
Your equipment is not maintained so that surfaces that contact components, in-process materials and PET drugs are not reactive, additive, or absorptive so as to alter the quality of the PET drugs. - Testing results 21 CFR 212.50(c)(8)
Your batch production record did not include testing results.
May 16, 2019 inspection
- Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures. - Equipment 21 CFR 212.60(e)
All equipment used to perform the testing is not suitable for its intended purposes.
Feb 28, 2018 inspection
- Written QA procedures established, followed 21 CFR 212.20(e)
You did not follow written quality assurance procedures. - Prevention of contamination 21 CFR 212.30(a)
Your facilities are not adequate to ensure the prevention of contamination of equipment and product by environmental conditions that could reasonably be expected to have an adverse effect on product quality. - Equipment not clean 21 CFR 212.30(b)
You did not implement procedures to ensure that all your equipment is clean. - Equipment not suitable 21 CFR 212.30(b)
You did not implement procedures to ensure that all your equipment is suitable for its intended purposes. - Equipment procedures overall 21 CFR 212.30(b)
You did not implement procedures to ensure that all your equipment is 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.
Registered with FDA for: positron emission tomography drug production.