Organ Recovery Systems, Inc. - Feb. 10, 2017
Issue Date
Feb 10, 2017
Region
Central
Category
Device
$117.00
Contact Name
Pedro Juan Padro
Contact Title
Director of Regulatory and Clinical Affairs
Address 1
One Pierce Place
Address 2
Ste. 475W
City
Itasca
State
IL
Zip/Postal Code
60143
Country
United States
Inspection Range
Jan 17, 2017 - Feb 10, 2017
Pages
4
First Observation
The results of design validation, including identification of the design, method(s), the date and the individual(s) performing validation, were not adequately documented in the design history file.
Investigator(s): David J. Gasparovich and Maksim A. Levenchuk