Thera Test Laboratories, Inc. - July 21, 2021
Issue Date
Jul 21, 2021
Region
Central
Category
Device
$117.00
Contact Name
Jeffrey S. Bandstra
Contact Title
VP of manufacturing
Address 1
1120 N. Du Page Ave.
City
Lombard
State
IL
Zip/Postal Code
60148-1247
Country
United States
Inspection Range
Jul 15, 2021 - Jul 21, 2021
Pages
4
First Observation
A correction or removal, conducted to reduce a risk to health posed by a device, was not reported in
writing to FDA.
Investigator(s): Shafiq S. Ahadi