LISI Medical Remmele, Inc. - July 12, 2022
Issue Date
Jul 12, 2022
Region
Central
Category
Device
$117.00
Contact Name
Jason D. Bastyr
Contact Title
Quality Manager
Address 1
441 93rd Ave. NW.
City
Coon Rapids
State
MN
Zip/Postal Code
55433-5803
Inspection Range
Jun 28, 2022 - Jul 12, 2022
Pages
5
First Observation
When test/measurement equipment was found to not meet accuracy and precision limits, inadequate action was taken to evaluate whether there was any adverse effect on the device's quality.
Investigator(s): Christina L. Bigham and Mildred J. Tures