NovaSom, Inc. - Feb. 5, 2014
Issue Date
Feb 05, 2014
Region
Central
Category
Device
$117.00
Contact Name
Michael P. Coppola, MD
Contact Title
Chief Medical and Compliance Officer
Address 1
801 Cromwell Park Dr.
Address 2
Suite 108
City
Glen Burnie
State
MD
Zip/Postal Code
21061-2539
Country
United States
Inspection Range
Jan 29, 2014 - Feb 05, 2014
Pages
3
First Observation
Acceptance activities were not adequately maintained as part of the device history record.
Investigator(s): Cynthia A. Harris