BSN Medical, Inc. - March 22, 2021
Issue Date
Mar 22, 2021
Region
Southeast
Category
Device
$117.00
Contact Name
Daniel Silvano
Contact Title
Quality Compliance Manager
Address 1
5825 Carnegie Blvd.
City
Charlotte
State
NC
Zip/Postal Code
28209-4633
Country
United States
Inspection Range
Mar 15, 2021 - Mar 22, 2021
Pages
4
First Observation
The design was not validated under defined operating conditions and using initial production units, lots or batches or their equivalents.
Investigator(s): Gamal A. Norton