Terumo Cardiovascular Systems Corp. - Sept. 12, 2016
Issue Date
Sep 15, 2016
Region
Central
Category
Device
$117.00
Contact Name
Louis F. Peticca
Contact Title
Plant Manager
Address 1
125 Blue Ball Rd.
City
Elkton
State
MD
Zip/Postal Code
21921
Country
United States
Inspection Range
Sep 12, 2016 - Sep 15, 2016
Pages
2
First Observation
Software used as part of production and the quality system has not been adequately validated for its intended use according to an established protocol.
Investigator(s): Marc S. Neubauer and James M. Simpson