Criticare Systems, Inc
Form 483 issued November 20, 2015 · Waukesha, Wisconsin
- Inspection
- Nov 2 – Nov 20, 2015
- Investigator
- Michelle J. Glembin
- Observations
- 3
- Pages
- 3
- FEI number
- 2183600
In short: On November 20, 2015, FDA issued a Form 483 with 3 observations to Criticare Systems, Inc in Waukesha, Wisconsin (FEI 2183600) after an inspection that ran Nov 2 – Nov 20, 2015. The investigator was Michelle J. Glembin. Most observations concern cAPA.
At a glance
3 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
Procedures have not been adequately established to control product that does not…
- 02
Procedures for receiving, reviewing, and evaluating complaints by a formally designated unit have…
- 03
Procedures for corrective and preventive action have…
This inspection in context
Michelle J. Glembin
5 documents · 2015–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Wisconsin.
The firmCriticare Systems, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Criticare Systems, Inc?
FDA listed 3 observations on this Form 483, mostly about cAPA. The opening words of each observation are shown on this page.
Who inspected Criticare Systems, Inc?
Michelle J. Glembin is named on this Form 483, for the inspection of Nov 2 – Nov 20, 2015. Each investigator has a profile showing what they cite most.
When was Criticare Systems, Inc inspected by FDA?
The inspection ran Nov 2 – Nov 20, 2015, and the Form 483 is dated November 20, 2015.
How do I get the full Form 483 for Criticare Systems, 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.