Enteromedics
Form 483 issued December 18, 2017 · Saint Paul, Minnesota
- Inspection
- Nov 28 – Dec 18, 2017
- Investigator
- Susan M. Matthias
- Observations
- 1
- Pages
- 6
- FEI number
- 3005025697
In short: On December 18, 2017, FDA issued a Form 483 with 1 observation to Enteromedics in Saint Paul, Minnesota (FEI 3005025697) after an inspection that ran Nov 28 – Dec 18, 2017. The investigator was Susan M. Matthias. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
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 firmEnteromedics history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Enteromedics?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Enteromedics?
Susan M. Matthias is named on this Form 483, for the inspection of Nov 28 – Dec 18, 2017. Each investigator has a profile showing what they cite most.
When was Enteromedics inspected by FDA?
The inspection ran Nov 28 – Dec 18, 2017, and the Form 483 is dated December 18, 2017.
How do I get the full Form 483 for Enteromedics?
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.