Natus Medical Incorporated
Form 483 issued July 27, 2016 · Seattle, Washington
- Inspection
- Jun 15 – Jul 27, 2016
- Investigators
- Cynthia L. Gorveatt· Sharon I. Gundersen
- Observations
- 12
- Pages
- 13
- FEI number
- 3018859
In short: On July 27, 2016, FDA issued a Form 483 with 12 observations to Natus Medical Incorporated in Seattle, Washington (FEI 3018859) after an inspection that ran Jun 15 – Jul 27, 2016. The investigators were Cynthia L. Gorveatt and Sharon I. Gundersen. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
2 of 2 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(c) (1×) · 820.30(f) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Design input requirements were…
- 02
Procedures for design verification have…
This inspection in context
Cynthia L. Gorveatt
2 documents · 2015–2016
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Washington.
The firmNatus Medical Incorporated 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 Natus Medical Incorporated?
FDA listed 12 observations on this Form 483, mostly about design 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 Natus Medical Incorporated?
Cynthia L. Gorveatt and Sharon I. Gundersen are named on this Form 483, for the inspection of Jun 15 – Jul 27, 2016. Each investigator has a profile showing what they cite most.
When was Natus Medical Incorporated inspected by FDA?
The inspection ran Jun 15 – Jul 27, 2016, and the Form 483 is dated July 27, 2016.
How do I get the full Form 483 for Natus Medical Incorporated?
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.