Theken Companies, LLC - Dec. 13, 2018
Issue Date
Dec 13, 2018
Region
Central
Category
Device
$117.00
Contact Name
Shekhar S. Ganore
Contact Title
Director of Quality Systems and Inspections
Address 1
1800 Triplett Blvd.
City
Akron
State
OH
Zip/Postal Code
44306-3311
Country
United States
Inspection Range
Dec 10, 2018 - Dec 13, 2018
Pages
3
First Observation
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of
information that reasonably suggests that a marketed device may have caused or contributed to a death or serious injury.
Investigator(s): Shannon A. Gregory