Drug factory · FDA FEI 3003849479
Aphena Pharma Solutions - Tennessee, LLC
1976 Chocolate Drive, Cookeville, TN, United States
No problems found at FDA's last inspection, Jul 25, 2022.
No Action Indicated: inspectors found no objectionable conditions.
22 drug inspections on record since 2010: 7 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Amlodipine | Repackages it | Aphena Pharma Solutions - Tennessee, Inc. | 71610-722 |
| Apixaban | Packages it and labels it | E.R. Squibb & Sons, L.L.C. | 0003-0893, 0003-0894, 0003-3764 |
| Eflornithine | Packages it and labels it | Uswm, LLC | 78670-150 |
| Lorazepam | Repackages it | Aphena Pharma Solutions - Tennessee, Inc. | 71610-654, 71610-655, 71610-674 |
| Terazosin | Repackages it | Aphena Pharma Solutions - Tennessee, Inc. | 71610-720 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 25, 2022 | No problems found | Drug Quality Assurance | — |
| Jul 25, 2022 | No problems found | Drug Quality Assurance | — |
| Jul 9, 2021 | No problems found | Drug Quality Assurance | — |
| Jul 9, 2021 | No problems found | Drug Quality Assurance | — |
| Nov 16, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 16, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 30, 2016 | No problems found | Drug Quality Assurance | — |
| Nov 30, 2016 | No problems found | Drug Quality Assurance | — |
| Jun 13, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 13, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 28, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 28, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 12, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 12, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 1, 2012 | No problems found | Drug Quality Assurance | — |
| Oct 1, 2012 | No problems found | Drug Quality Assurance | — |
| Aug 4, 2011 | No problems found | Drug Quality Assurance | — |
| Aug 4, 2011 | No problems found | Drug Quality Assurance | — |
| Aug 20, 2010 | No problems found | Drug Quality Assurance | — |
| Aug 20, 2010 | No problems found | Drug Quality Assurance | — |
| Feb 19, 2010 | No problems found | Drug Quality Assurance | — |
| Feb 19, 2010 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: label; pack; relabel; repack.