AbbVie Inc.
Form 483 issued July 2, 2018 · North Chicago, Illinois
- Inspection
- May 15 – Jul 2, 2018
- Observations
- 1
- Pages
- 5
- FEI number
- 3009751352
In short: On July 2, 2018, FDA issued a Form 483 with 1 observation to AbbVie Inc. in North Chicago, Illinois (FEI 3009751352) after an inspection that ran May 15 – Jul 2, 2018. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences).
What FDA observed
Preview: the opening words of each observation- 01
Not all adverse drug experiences that are both serious and unexpected have been reported to FDA…
This inspection in context
Questions about this 483
What did FDA find at AbbVie Inc.?
FDA listed 1 observation on this Form 483. The most-cited regulation is 21 CFR 314.80 (postmarketing reporting of adverse drug experiences). The opening words of each observation are shown on this page.
When was AbbVie Inc. inspected by FDA?
The inspection ran May 15 – Jul 2, 2018, and the Form 483 is dated July 2, 2018.
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.