Drug factory · FDA FEI 1021320
SpecGx LLC
8801 Capital Blvd., Raleigh, NC, United States
Problems found, fixed voluntarily at FDA's last inspection, Sep 22, 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: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Acetaminophen and Benzhydrocodone | Tests it | Zevra Therapeutics, Inc. | 70040-0145, 70040-0167, 70040-0189 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 22, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jan 25, 2019 | No problems found | Drug Quality Assurance | — |
| Aug 26, 2014 | No problems found | Drug Quality Assurance | — |
| Jul 21, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.