Medivators, Inc.
Form 483 issued May 12, 2015 · Plymouth, Minnesota
- Inspection
- Apr 9 – May 12, 2015
- Investigator
- Susan M. Matthias
- Observations
- 4
- Pages
- 3
- FEI number
- 2150060
In short: On May 12, 2015, FDA issued a Form 483 with 4 observations to Medivators, Inc. in Plymouth, Minnesota (FEI 2150060) after an inspection that ran Apr 9 – May 12, 2015. The investigator was Susan M. Matthias. Most observations concern design controls and records & documents; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and records & documents account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design validation have…
- 02
Design output was not…
- 03
Document control procedures have…
- 04
A process whose results cannot be fully verified by subsequent inspection and test has not been…
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 firmMedivators, Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medivators, Inc.?
FDA listed 4 observations on this Form 483, mostly about design controls, records & documents and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Medivators, Inc.?
Susan M. Matthias is named on this Form 483, for the inspection of Apr 9 – May 12, 2015. Each investigator has a profile showing what they cite most.
When was Medivators, Inc. inspected by FDA?
The inspection ran Apr 9 – May 12, 2015, and the Form 483 is dated May 12, 2015.
How do I get the full Form 483 for Medivators, 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.