Inspire Medical Systems Inc.
Form 483 issued June 22, 2018 · Maple Grove, Minnesota
- Inspection
- Jun 18 – Jun 22, 2018
- Investigator
- Susan M. Matthias
- Observations
- 1
- Pages
- 4
- FEI number
- 3007666314
In short: On June 22, 2018, FDA issued a Form 483 with 1 observation to Inspire Medical Systems Inc. in Maple Grove, Minnesota (FEI 3007666314) after an inspection that ran Jun 18 – Jun 22, 2018. The investigator was Susan M. Matthias. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 803.50(a)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
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 firmInspire Medical Systems Inc. history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Inspire Medical Systems Inc.?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Inspire Medical Systems Inc.?
Susan M. Matthias is named on this Form 483, for the inspection of Jun 18 – Jun 22, 2018. Each investigator has a profile showing what they cite most.
When was Inspire Medical Systems Inc. inspected by FDA?
The inspection ran Jun 18 – Jun 22, 2018, and the Form 483 is dated June 22, 2018.
How do I get the full Form 483 for Inspire Medical Systems 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.