Criticare Systems, Inc
FDA inspection history in Waukesha, Wisconsin, 2015
- 1
- Form 483
Every document, by year
- Form 483
2015: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Waukesha, Wisconsin.
Cited most
Across all Criticare Systems observations on file
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.198(a)Complaint files1
- 21 CFR 820.90(a)Nonconforming product1
The complete Criticare Systems file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Waukesha, Wisconsin
One Form 483 · 2015 · 3 observations
Latest: Form 483, Nov 20, 2015 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-11-20 | 483 Form 483 | Waukesha, Wisconsin | 3 | $99 |
Investigators on these documents
FEI number 2183600 · most recent document Nov 20, 2015
About Criticare Systems, Inc
How many FDA Form 483s has Criticare Systems, Inc received?
FDA Intel has 1 Form 483 on file for Criticare Systems, Inc; the most recent is dated Nov 20, 2015.
When was Criticare Systems, Inc last inspected by FDA?
The most recent FDA inspection document on file for Criticare Systems, Inc is a Form 483 dated Nov 20, 2015, for the site in Waukesha, Wisconsin.
What did FDA cite at Criticare Systems, Inc?
The regulations cited most in the observations on file for Criticare Systems, Inc are 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.198(a) (Complaint files), 1 time; 21 CFR 820.90(a) (Nonconforming product), 1 time.