Drug factory · FDA FEI 1940521
SpecGx LLC
3600 N. 2nd Street, St. Louis, MO, United States
Problems found, fixed voluntarily at FDA's last inspection, Oct 22, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
8 drug inspections on record since 2010: 5 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|
| Acetaminophen and Codeine | Makes the active ingredient |
SpecGx LLC |
0406-0483, 0406-0484, 0406-0485 |
| Acetaminophen and Hydrocodone | Makes the active ingredient |
Golden State Medical Supply, Inc., SpecGx LLC |
60429-590, 60429-591, 60429-592 +6 |
| Acetaminophen and Oxycodone | Makes the active ingredient |
SpecGx LLC |
0406-0512, 0406-0522, 0406-0523 |
| Amphetamine and Dextroamphetamine | Makes the active ingredient |
SpecGx LLC |
0406-0803, 0406-0804, 0406-0805 +1 |
| Buprenorphine and Naloxone | Makes the active ingredient and tests it |
Indivior Inc. |
12496-1202, 12496-1204, 12496-1208 +1 |
| Dextroamphetamine | Makes the active ingredient |
SpecGx LLC |
0406-8960, 0406-8961, 0406-8962 |
| Fentanyl | Makes the active ingredient |
SpecGx LLC |
0406-9037, 0406-9062, 0406-9100 +4 |
| Ioversol | Makes the active ingredient |
Liebel-Flarsheim Company LLC |
0019-1323, 0019-1332, 0019-1333 |
| Methadone | Makes the active ingredient and tests it |
SpecGx LLC |
0406-0527, 0406-6221, 0406-6225 +1 |
| Methylphenidate | Makes the active ingredient |
Shionogi Inc., SpecGx LLC |
59630-750, 59630-755, 0406-1142 +2 |
| Morphine | Makes the active ingredient and tests it |
Nortec Development Associates, Inc., SpecGx LLC |
42689-005, 42689-006, 42689-007 +11 |
| Oxycodone | Makes the active ingredient and tests it |
SpecGx LLC |
0406-8556, 0406-8557 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|
| Oct 22, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 11, 2022 | No problems found | Drug Quality Assurance | — |
| Sep 12, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 22, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 12, 2014 | No problems found | Drug Quality Assurance | — |
| May 24, 2013 | No problems found | Drug Quality Assurance | — |
| Jun 4, 2010 | No problems found | Drug Quality Assurance | — |
| Apr 26, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.