ICU Medical
Form 483 issued April 8, 2016 · Dublin, Ohio
- Inspection
- Apr 8, 2016
- Investigator
- Rosanna M. Goodrich
- Observations
- 4
- Pages
- 4
- FEI number
- 1526863
In short: On April 8, 2016, FDA issued a Form 483 with 4 observations to ICU Medical in Dublin, Ohio (FEI 1526863) after an inspection that ran Apr 8, 2016. The investigator was Rosanna M. Goodrich. Most observations concern cAPA and production & process controls.
At a glance
CAPA and production & process 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
The equipment used in the manufacturing process does…
- 02
Procedures for training and identifying training needs have…
- 03
Procedures have not been adequately established to control product that does not…
- 04
Complaint files are not…
This inspection in context
Rosanna M. Goodrich
13 documents · 2015–2025
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Ohio.
The firmICU Medical history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.70
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at ICU Medical?
FDA listed 4 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The opening words of each observation are shown on this page.
Who inspected ICU Medical?
Rosanna M. Goodrich is named on this Form 483, for the inspection of Apr 8, 2016. Each investigator has a profile showing what they cite most.
When was ICU Medical inspected by FDA?
The inspection ran Apr 8, 2016, and the Form 483 is dated April 8, 2016.
How do I get the full Form 483 for ICU Medical?
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.