Drug factory · FDA FEI 3006337946
Shanghai SynTheAll Pharmaceutical Co., Ltd.
No. 9, Yuegong Road, Jinshan District, Shanghai, China
Problems found, fixed voluntarily at FDA's last inspection, Apr 25, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2013: 3 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Abiraterone and Niraparib | Makes the active ingredient and tests it | Janssen Biotech, Inc. | 57894-050, 57894-100 |
| Elexacaftor and Ivacaftor and Tezacaftor | Makes the active ingredient and tests it | Vertex Pharmaceuticals Incorporated | 51167-106, 51167-331, 51167-445 +1 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 25, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jul 19, 2018 | No problems found | Drug Quality Assurance | — |
| Apr 8, 2016 | No problems found | Drug Quality Assurance | — |
| Jul 17, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 15, 2013 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.