ICU Medical
FDA inspection history in Dublin, Ohio, 2016
- 1
- Form 483
Every document, by year
- Form 483
2016: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Dublin, Ohio.
Cited most
Across all ICU Medical observations on file
- 21 CFR 820.198Complaint files1
- 21 CFR 820.25Personnel1
- 21 CFR 820.70Production and process controls1
- 21 CFR 820.90Nonconforming product1
The complete ICU Medical file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Dublin, Ohio
One Form 483 · 2016 · 4 observations
Latest: Form 483, Apr 8, 2016 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-04-08 | 483 Form 483 | Dublin, Ohio | 4 | $99 |
Investigators on these documents
FEI number 1526863 · most recent document Apr 8, 2016
About ICU Medical
How many FDA Form 483s has ICU Medical received?
FDA Intel has 1 Form 483 on file for ICU Medical; the most recent is dated Apr 8, 2016.
When was ICU Medical last inspected by FDA?
The most recent FDA inspection document on file for ICU Medical is a Form 483 dated Apr 8, 2016, for the site in Dublin, Ohio.
What did FDA cite at ICU Medical?
The regulations cited most in the observations on file for ICU Medical are 21 CFR 820.198 (Complaint files), 1 time; 21 CFR 820.25 (Personnel), 1 time; 21 CFR 820.70 (Production and process controls), 1 time.