CompView Medical, LLC - June 20, 2014
Issue Date
Jun 20, 2014
Region
Pacific
Category
Device
$117.00
Contact Name
Anna C. Breitbach
Contact Title
RA/QA Manager
Address 1
10101 SW Artic Dr.
City
Beaverton
State
OR
Zip/Postal Code
97005
Country
United States
Inspection Range
Jun 18, 2014 - Jun 20, 2014
Pages
2
First Observation
Procedures for finished device acceptance have not been adequately established. Specifically, During review of 37 device history records covering the manufacture and test of NuBoomU M4 and NuBOOM M2 devices since August 2012, I observed your firm failed to document finished device review and acceptance on the DOCS Rack Production Traveler prior to releasing ** of the devices for shipment. The production records were signed and dated indicating release for shipment after the products had been picked up or shipped from your manufacturing facility.
Investigator(s): James D. Hildreth