Arrow International, Inc. - June 20, 2016
Issue Date
Jun 20, 2016
Region
Central
Category
Device
$117.00
Contact Name
Jackie Hollenbach
Contact Title
Vice President, Research & Development, Vascular Division
Address 1
2400 Bernville Rd.
City
Reading
State
PA
Zip/Postal Code
19605-9607
Country
United States
Inspection Range
Jun 09, 2016 - Jun 20, 2016
Pages
2
First Observation
Production processes were not conducted to ensure that a device conforms to its specifications.
Investigator(s): Jacob M. Dyer and Brian S. Keefer