Organ Recovery Systems, Inc. - April 7, 2015
Issue Date
Apr 07, 2015
Region
Central
Category
Device
$117.00
Contact Name
David C. Kravits
Contact Title
President/CEO
Address 1
One Pierce Pl.
Address 2
Ste. 475 West
City
Itasca
State
IL
Zip/Postal Code
60143
Country
United States
Inspection Range
Mar 25, 2015 - Apr 07, 2015
Pages
5
First Observation
The written MDR procedure does not include an internal system which provides for the timely and effective identification of events that may be subject to medical device reporting requirements.
Investigator(s): Amanda Dinaro and Jesse A. Vazquez