Monteris Medical Corp
Form 483 issued June 30, 2016 · Plymouth, Minnesota
- Inspection
- Jun 13 – Jun 30, 2016
- Investigator
- Susan M. Matthias
- Observations
- 5
- Pages
- 3
- FEI number
- 3009970070
In short: On June 30, 2016, FDA issued a Form 483 with 5 observations to Monteris Medical Corp in Plymouth, Minnesota (FEI 3009970070) after an inspection that ran Jun 13 – Jun 30, 2016. The investigator was Susan M. Matthias. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 3 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Design input requirements were…
- 02
Procedures for design change have…
- 03
Service reports do not…
- 04
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
This inspection in context
Susan M. Matthias
10 documents · 2013–2019
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Minnesota.
The firmMonteris Medical Corp history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Monteris Medical Corp?
FDA listed 5 observations on this Form 483, mostly about design controls, production & process controls and cAPA. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Monteris Medical Corp?
Susan M. Matthias is named on this Form 483, for the inspection of Jun 13 – Jun 30, 2016. Each investigator has a profile showing what they cite most.
When was Monteris Medical Corp inspected by FDA?
The inspection ran Jun 13 – Jun 30, 2016, and the Form 483 is dated June 30, 2016.
How do I get the full Form 483 for Monteris Medical Corp?
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.