Polarean, Inc. - Sept. 7, 2021
Issue Date
Sep 07, 2021
Region
Southeast
Category
Device
$117.00
Contact Name
Neil Wadehra
Contact Title
VP of Operations
Address 1
2500 Meridian Pkwy.
Address 2
Ste. 175
City
Durham
State
NC
Zip/Postal Code
27713-4214
Country
United States
Inspection Range
Aug 30, 2021 - Sep 07, 2021
Pages
4
First Observation
The design was not validated using initial production units, lots or batches or their equivalents.
Investigator(s): Seneca D. Toms