AbbVie Biotechnology LTD
FDA inspection history in Barceloneta, Puerto Rico, 2016 to 2023
- 4
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2017: one Form 483; 2019: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016–19Three Form 483s, at Barceloneta, Puerto Rico.
- 2016The longest 483 on file: 8 observations over 5 pages at Barceloneta, Puerto Rico.
- 2023One Form 483, at Barceloneta, Puerto Rico.
Cited most
Across all AbbVie Biotechnology observations on file
- 21 CFR 211.192Production record review4
- 21 CFR 211.160General requirements3
- 21 CFR 211.198Complaint files3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
The complete AbbVie Biotechnology file.
All 4 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Barceloneta, Puerto Rico
Four Form 483s · 2016 to 2023 · 15 observations
Latest: Form 483, Oct 30, 2023 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-10-30 | 483 Form 483 | Barceloneta, Puerto Rico | 1 | $99 |
| 2019-03-25 | 483 Form 483 | Barceloneta, Puerto Rico | 3 | $99 |
| 2017-04-28 | 483 Form 483 | Barceloneta, Puerto Rico | 3 | $99 |
| 2016-03-24 | 483 Form 483 | Barceloneta, Puerto Rico | 8 | $99 |
Investigators on these documents
FEI number 3004620772 · most recent document Oct 30, 2023
About AbbVie Biotechnology LTD
How many FDA Form 483s has AbbVie Biotechnology LTD received?
FDA Intel has 4 Form 483s on file for AbbVie Biotechnology LTD; the most recent is dated Oct 30, 2023.
When was AbbVie Biotechnology LTD last inspected by FDA?
The most recent FDA inspection document on file for AbbVie Biotechnology LTD is a Form 483 dated Oct 30, 2023, for the site in Barceloneta, Puerto Rico.
What did FDA cite at AbbVie Biotechnology LTD?
The regulations cited most in the observations on file for AbbVie Biotechnology LTD are 21 CFR 211.192 (Production record review), 4 times; 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.198 (Complaint files), 3 times.