Drug factory · FDA FEI 3007163376
Huons Co., Ltd.
100, Bio valley-ro, Jecheon-si, South Korea
Serious problems, FDA action at FDA's last inspection, Nov 21, 2025.
Official Action Indicated: inspectors found significant problems and FDA recommended regulatory action, such as a warning letter or import alert.
3 drug inspections on record since 2016: 0 with no problems, 2 with problems fixed voluntarily, 1 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bupivacaine | Makes it | Huons Co., Ltd. | 73293-0002 |
| Chloride Ion | Makes it | Spectra Medical Deviecs, LLC | 65282-1505, 65282-1510 |
| Lidocaine | Makes it | Huons Co., Ltd., NextSource Biotechnology, LLC, Novagenix Labs LLC, Spectra Medical Deviecs, LLC | 73293-0001, 73293-0003, 73293-0004 +8 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 21, 2025 | Serious problems, FDA action | Drug Quality Assurance | — |
| Oct 18, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 2, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: manufacture.