Drug factory · FDA FEI 3004587193
Hanmi Fine Chemical Co., Ltd
Siheung, Korea (the Republic of)
Matched to FDA's records by company name, because this plant's registration on the label has expired.
No problems found at FDA's last inspection, Nov 25, 2022.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2011: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Esomeprazole | Makes the active ingredient | Amneal Pharmaceuticals | 53746-955, 53746-957 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 25, 2022 | No problems found | Drug Quality Assurance | — |
| Jun 15, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 10, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 5, 2013 | No problems found | Drug Quality Assurance | — |
| Mar 10, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |