Bioject Medical Technologies, Inc. - March6, 2014
Issue Date
Mar 06, 2014
Region
Pacific
Category
Device
$117.00
Contact Name
Richard R. Stout
Contact Title
Executive Vice President
Address 1
7180 SW Sandburg St.
Address 2
Ste. 100
City
Tigard
State
OR
Zip/Postal Code
97223-8163
Country
United States
Inspection Range
Mar 03, 2014 - Mar 06, 2014
Pages
3
First Observation
Procedures for monitoring and control of process parameters for a validated process have not been adequately established.
Investigator(s): Stanley B. Eugene