Drug factory · FDA FEI 3012163998
Hugel, Inc.
23, Geodudanji 1-gil, Dongnae-myeon, Chuncheon-si, South Korea
Problems found, fixed voluntarily at FDA's last inspection, Oct 19, 2023.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
1 drug inspection on record since 2023: 0 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Letibotulinumtoxina | Makes it, makes the active ingredient, tests it, packages it and labels it | Hugel, Inc. | 81165-050, 81165-100 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 19, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; label; manufacture; pack.