AbbVie Inc.
Form 483 issued January 31, 2023 · North Chicago, Illinois
- Inspection
- Jan 23 – Jan 31, 2023
- Investigators
- Lauren N. Howard· Robert J. Ham
- Observations
- 5
- Pages
- 11
- FEI number
- 3009751352
In short: On January 31, 2023, FDA issued a Form 483 with 5 observations to AbbVie Inc. in North Chicago, Illinois (FEI 3009751352) after an inspection that ran Jan 23 – Jan 31, 2023. The investigators were Lauren N. Howard and Robert J. Ham. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
3 of 5 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Written records of investigations into unexplained discrepancies and the failure of a batch or any of…
- 02
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 03
The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on…
- 04
The responsibilities and procedures applicable to the quality unit are not in…
This inspection in context
Lauren N. Howard
14 documents · 2017–2025
Cites FDCA 501(a)(2)(A) (insanitary conditions) more than any other section. Most of their documents are for sites in Ohio.
The firmAbbVie Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AbbVie Inc.?
FDA listed 5 observations on this Form 483, mostly about quality system, laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected AbbVie Inc.?
Lauren N. Howard and Robert J. Ham are named on this Form 483, for the inspection of Jan 23 – Jan 31, 2023. Each investigator has a profile showing what they cite most.
When was AbbVie Inc. inspected by FDA?
The inspection ran Jan 23 – Jan 31, 2023, and the Form 483 is dated January 31, 2023.
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.