iRhythm Technologies, Inc. - Aug. 12, 2022
Issue Date
Aug 12, 2022
Region
Pacific
Category
Device
$117.00
Contact Name
Mark W. Hughes
Contact Title
Vice President of Manufacturing
Address 1
6550 Katella Ave.
City
Cypress
State
CA
Zip/Postal Code
90630-5102
Inspection Range
Jul 25, 2022 - Aug 12, 2022
Pages
8
First Observation
Procedures for corrective and preventive action have not been adequately established.
Investigator(s): Alexandria L. Capuano and Janet Pulver