Virginia Mason Medical Center
Form 483 issued April 15, 2016 · Seattle, Washington
- Inspection
- Dec 8, 2015 – Apr 15, 2016
- Investigators
- Christopher S. Genther· Sharon I. Gundersen· Stephen R. Souza
- Observations
- 4
- Pages
- 4
- FEI number
- 3001239271
In short: On April 15, 2016, FDA issued a Form 483 with 4 observations to Virginia Mason Medical Center in Seattle, Washington (FEI 3001239271) after an inspection that ran Dec 8, 2015 – Apr 15, 2016. The investigators were Christopher S. Genther, Sharon I. Gundersen and Stephen R. Souza. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.18 (what are the requirements for establishing and maintaining MDR files or records that apply to me?).
At a glance
4 of 4 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
MDR event files do not contain or reference all adverse event information in the possession of…
- 02
The user facility did not submit FDA Form 3500A or electronic equivalent to the known device…
- 03
An authorized FDA employee was not permitted to copy MDR required…
- 04
Written MDR procedures have…
This inspection in context
Christopher S. Genther
4 documents · 2016–2022
Cites 803.17 (what are the requirements for developing, maintaining, and implementing written mdr procedures that apply to me?) more than any other section. Most of their documents are for sites in Washington.
The firmVirginia Mason Medical Center history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.18(b)(1)(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Virginia Mason Medical Center?
FDA listed 4 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.18 (what are the requirements for establishing and maintaining MDR files or records that apply to me?). The opening words of each observation are shown on this page.
Who inspected Virginia Mason Medical Center?
Christopher S. Genther, Sharon I. Gundersen and Stephen R. Souza are named on this Form 483, for the inspection of Dec 8, 2015 – Apr 15, 2016. Each investigator has a profile showing what they cite most.
When was Virginia Mason Medical Center inspected by FDA?
The inspection ran Dec 8, 2015 – Apr 15, 2016, and the Form 483 is dated April 15, 2016.
How do I get the full Form 483 for Virginia Mason Medical Center?
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.