Pinnacle Biologics, Inc. - June 27, 2022
Issue Date
Jun 27, 2022
Region
Central
Category
Device
$117.00
Contact Name
Glenn M. Kutschera
Contact Title
President and General Manager
Address 1
2801 Lakeside Dr.
Address 2
Ste. 210
City
Bannockburn
State
IL
Zip/Postal Code
60015-1200
Inspection Range
Jun 22, 2022 - Jun 27, 2022
Pages
4
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 has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.
Investigator(s): Shafiq S. Ahadi