Parks Medical Electronics, Inc. - June 17, 2016
Issue Date
Jun 17, 2016
Region
Pacific
Category
Device
$117.00
Contact Name
Todd C. Welker
Contact Title
Quality System Administrator
Address 1
19460 S.W. Shaw St.
City
Aloha
State
OR
Zip/Postal Code
97078-1242
Country
United States
Inspection Range
Jun 06, 2016 - Jun 17, 2016
Pages
5
First Observation
The results of design validation, including method(s), the date and the individual(s) performing
validation, were not adequately documented in the design history file.
Investigator(s): Stanley B. Eugene and Celia L. Silverstein