Ninepoint Medical, Inc. - Oct. 24, 2016
Issue Date
Oct 24, 2016
Region
Northeast
Category
Device
$117.00
Contact Name
Christopher von Jako
Contact Title
President and CEO
Address 1
12 Oak Park Dr.
City
Bedford
State
MA
Zip/Postal Code
01731
Country
United States
Inspection Range
Oct 18, 2016 - Oct 24, 2016
Pages
1
First Observation
The design was not validated using initial production units, lots or batches or their equivalents.
Investigator(s): John A. Sciacchitano