Evergreen Orthopedic Research Lab, LLC
Form 483 issued October 29, 2015 · Kirkland, Washington
- Inspection
- Oct 21 – Oct 29, 2015
- Investigator
- Sharon I. Gundersen
- Observations
- 3
- Pages
- 3
- FEI number
- 3007190523
In short: On October 29, 2015, FDA issued a Form 483 with 3 observations to Evergreen Orthopedic Research Lab, LLC in Kirkland, Washington (FEI 3007190523) after an inspection that ran Oct 21 – Oct 29, 2015. The investigator was Sharon I. Gundersen. Most observations concern design controls and records & documents; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
2 of 3 observations on this 483 concern design controls.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design verification have not…
- 02
Procedures for design validation have…
- 03
A device history record has…
This inspection in context
Sharon I. Gundersen
3 documents · 2015–2016
Cites 820.30(c) (design controls) more than any other section. Most of their documents are for sites in Washington.
The firmEvergreen Orthopedic Research Lab, LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.30(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Evergreen Orthopedic Research Lab, LLC?
FDA listed 3 observations on this Form 483, mostly about design controls and records & documents. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Evergreen Orthopedic Research Lab, LLC?
Sharon I. Gundersen is named on this Form 483, for the inspection of Oct 21 – Oct 29, 2015. Each investigator has a profile showing what they cite most.
When was Evergreen Orthopedic Research Lab, LLC inspected by FDA?
The inspection ran Oct 21 – Oct 29, 2015, and the Form 483 is dated October 29, 2015.
How do I get the full Form 483 for Evergreen Orthopedic Research Lab, LLC?
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.