Drug factory · FDA FEI 1411365
AbbVie Inc.
1401 Sheridan Road, North Chicago, IL, United States
No problems found at FDA's last inspection, Mar 3, 2026.
No Action Indicated: inspectors found no objectionable conditions.
10 drug inspections on record since 2009: 7 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oritavancin | Makes it, makes the active ingredient and tests it | Melinta Therapeutics, LLC | 70842-140, 70842-225 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 3, 2026 | No problems found | Drug Quality Assurance | — |
| Jun 18, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 24, 2018 | No problems found | Drug Quality Assurance | — |
| Aug 6, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 1, 2013 | No problems found | Drug Quality Assurance | — |
| Dec 22, 2011 | No problems found | Drug Quality Assurance | — |
| Jul 13, 2011 | No problems found | Drug Quality Assurance | — |
| Feb 1, 2010 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 23, 2009 | No problems found | Drug Quality Assurance | — |
| Mar 30, 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.
Aug 6, 2015 inspection
- Procedures to be written and followed 21 CFR 211.198(a)
Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.
Registered with FDA for: analysis; api manufacture; manufacture.