Drug factory · FDA FEI 3012007381
ST Pharm Co., Ltd.
171, Haean-ro, Danwon-gu, Ansan, South Korea
Problems found, fixed voluntarily at FDA's last inspection, Jul 14, 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 |
|---|---|---|---|
| Gadolinium Cation (3+) | Makes the active ingredient and tests it | GE Healthcare Inc. | 0407-1066 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 14, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; pack.