Monteris Medical Corp
FDA inspection history in Plymouth, Minnesota, 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 Plymouth, Minnesota.
Cited most
Across all Monteris Medical observations on file
- 21 CFR 820.30(c)Design controls2
- 21 CFR 1002.13Annual reports1
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.200(d)Servicing1
The complete Monteris Medical file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Plymouth, Minnesota
One Form 483 · 2016 · 5 observations
Latest: Form 483, Jun 30, 2016 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2016-06-30 | 483 Form 483 | Plymouth, Minnesota | 5 | $99 |
Investigators on these documents
FEI number 3009970070 · most recent document Jun 30, 2016
About Monteris Medical Corp
How many FDA Form 483s has Monteris Medical Corp received?
FDA Intel has 1 Form 483 on file for Monteris Medical Corp; the most recent is dated Jun 30, 2016.
When was Monteris Medical Corp last inspected by FDA?
The most recent FDA inspection document on file for Monteris Medical Corp is a Form 483 dated Jun 30, 2016, for the site in Plymouth, Minnesota.
What did FDA cite at Monteris Medical Corp?
The regulations cited most in the observations on file for Monteris Medical Corp are 21 CFR 820.30(c) (Design controls), 2 times; 21 CFR 1002.13 (Annual reports), 1 time; 21 CFR 803.50(a)(2) (If I am a manufacturer, what reporting requirements apply to me?), 1 time.