AbbVie Inc.
Form 483 issued August 6, 2015 · North Chicago, Illinois
- Inspection
- Jul 13 – Aug 6, 2015
- Investigator
- Nicholas P. Diorio
- Observations
- 1
- Pages
- 2
- FEI number
- 1411365
In short: On August 6, 2015, FDA issued a Form 483 with 1 observation to AbbVie Inc. in North Chicago, Illinois (FEI 1411365) after an inspection that ran Jul 13 – Aug 6, 2015. The investigator was Nicholas P. Diorio. Most observations concern quality system; the most-cited regulation is 21 CFR 211.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.198(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures describing the handling of all written and oral complaints regarding a drug…
This inspection in context
Nicholas P. Diorio
8 documents · 2013–2025
Cites 211.165(a) (testing and release for distribution) more than any other section. Most of their documents are for sites in Illinois.
The firmAbbVie Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.198(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AbbVie Inc.?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected AbbVie Inc.?
Nicholas P. Diorio is named on this Form 483, for the inspection of Jul 13 – Aug 6, 2015. Each investigator has a profile showing what they cite most.
When was AbbVie Inc. inspected by FDA?
The inspection ran Jul 13 – Aug 6, 2015, and the Form 483 is dated August 6, 2015.
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.