Drug factory · FDA FEI 1710165
Corden Pharma Colorado, Inc.
2075 55th Street, Boulder, CO, United States
No problems found at FDA's last inspection, Nov 14, 2025.
No Action Indicated: inspectors found no objectionable conditions.
11 drug inspections on record since 2009: 5 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Lonafarnib | Makes the active ingredient and tests it | Eiger BioPharmaceuticals, Inc. | 73079-050, 73079-075 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 14, 2025 | No problems found | Drug Quality Assurance | — |
| Feb 6, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 30, 2018 | No problems found | Drug Quality Assurance | — |
| May 2, 2016 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 12, 2016 | No problems found | Drug Quality Assurance | — |
| Jun 28, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 15, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 11, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 21, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 11, 2010 | No problems found | Drug Quality Assurance | — |
| Dec 9, 2009 | No problems found | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Feb 6, 2019 inspection
- Deviations from laboratory control requirements 21 CFR 211.160(a)
Deviations from written test procedures are not justified.
Registered with FDA for: analysis; api manufacture.