Drug factory · FDA FEI 3009751352
AbbVie Inc.
1 N Waukegan Rd, North Chicago, IL, United States
No problems found at FDA's last inspection, Apr 27, 2026.
No Action Indicated: inspectors found no objectionable conditions.
19 drug inspections on record since 2013: 14 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Dexlansoprazole | Packages it and labels it | TWi Pharmaceuticals, Inc. | 24979-703, 24979-704 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 27, 2026 | No problems found | Drug Quality Assurance | — |
| Apr 2, 2026 | No problems found | Bioresearch Monitoring | — |
| Aug 21, 2025 | No problems found | Bioresearch Monitoring | — |
| Apr 19, 2024 | No problems found | Bioresearch Monitoring | — |
| Jan 31, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 6, 2022 | No problems found | Bioresearch Monitoring | — |
| Dec 15, 2021 | Problems found, fixed voluntarily | Bioresearch Monitoring | — |
| Feb 15, 2019 | No problems found | Bioresearch Monitoring | — |
| Nov 16, 2018 | No problems found | Bioresearch Monitoring | — |
| Jul 2, 2018 | Problems found, fixed voluntarily | Bioresearch Monitoring | 1 |
| Dec 15, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 4, 2016 | No problems found | Bioresearch Monitoring | — |
| Dec 16, 2015 | No problems found | Drug Quality Assurance | — |
| Nov 18, 2014 | No problems found | Drug Quality Assurance | — |
| Sep 29, 2014 | No problems found | Bioresearch Monitoring | — |
| Jun 6, 2014 | No problems found | Bioresearch Monitoring | — |
| Dec 13, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 4, 2013 | No problems found | Drug Quality Assurance | — |
| Apr 25, 2013 | 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.
Jul 2, 2018 inspection
- Late submission of 15-day report 21 CFR 314.80(c)(1)(i)
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA within 15 calendar days of initial receipt of the information.
Registered with FDA for: analysis; label; manufacture; pack.