AbbVie Inc.
Form 483 issued December 15, 2017 · North Chicago, Illinois
- Inspection
- Nov 27 – Dec 15, 2017
- Investigators
- Debra I. Love· Michele Perry Williams· Robert J. Ham
- Observations
- 4
- Pages
- 5
- FEI number
- 3009751352
In short: On December 15, 2017, FDA issued a Form 483 with 4 observations to AbbVie Inc. in North Chicago, Illinois (FEI 3009751352) after an inspection that ran Nov 27 – Dec 15, 2017. The investigators were Debra I. Love, Michele Perry Williams and Robert J. Ham. Most observations concern quality system and laboratory controls.
At a glance
Quality system and laboratory controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures describing the handling of written and oral complaints related to drug…
- 02
Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures…
- 03
Investigations of a failure of a batch or any of its components to meet any of…
- 04
Written production and process control procedures are not followed in the execution of production…
This inspection in context
Debra I. Love
13 documents · 2009–2018
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Illinois.
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 211.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at AbbVie Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, laboratory controls and production. The opening words of each observation are shown on this page.
Who inspected AbbVie Inc.?
Debra I. Love, Michele Perry Williams and Robert J. Ham are named on this Form 483, for the inspection of Nov 27 – Dec 15, 2017. Each investigator has a profile showing what they cite most.
When was AbbVie Inc. inspected by FDA?
The inspection ran Nov 27 – Dec 15, 2017, and the Form 483 is dated December 15, 2017.
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.