Drug factory · FDA FEI 3005275960
SpecGx LLC
381 & 385 Marshall Ave, Webster Groves, MO, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 18, 2023.
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 2018: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lisdexamfetamine | Makes it | SpecGx LLC | 0406-5124, 0406-5125, 0406-5126 +3 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 18, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Mar 16, 2020 | No problems found | Bioresearch Monitoring | — |
| Mar 6, 2019 | No problems found | Bioresearch Monitoring | — |
| Jan 26, 2018 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; manufacture.