AbbVie Inc.
Form 483 issued June 18, 2024 · North Chicago, Illinois
- Inspection
- Jun 11 – Jun 18, 2024
- Observations
- 1
- Pages
- 3
- FEI number
- 1411365
In short: On June 18, 2024, FDA issued a Form 483 with 1 observation to AbbVie Inc. in North Chicago, Illinois (FEI 1411365) after an inspection that ran Jun 11 – Jun 18, 2024. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to…
This inspection in context
Questions about this 483
What did FDA find at AbbVie Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
When was AbbVie Inc. inspected by FDA?
The inspection ran Jun 11 – Jun 18, 2024, and the Form 483 is dated June 18, 2024.
How do I get the full Form 483 for AbbVie Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.