Drug factory · FDA FEI 3007060980
Asymchem Life Science (Tianjin) Co., Ltd.
No. 71, 7th Avenue, TEDA Tianjin, Tianjin, China
Problems found, fixed voluntarily at FDA's last inspection, Mar 21, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2011: 2 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Piflufolastat F-18 | Makes the active ingredient | Progenics Pharmaceuticals, Inc. | 71258-022 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 21, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 26, 2018 | No problems found | Drug Quality Assurance | — |
| May 22, 2014 | No problems found | Drug Quality Assurance | — |
| May 18, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture; manufacture.