Unipower Corp. - Sept. 20, 2018
Issue Date
Sep 20, 2018
Region
Central
Category
Device
$117.00
Contact Name
Ronald A. Olsten
Contact Title
General Manager
Address 1
1157 Valley Park Dr.
Address 2
Ste. 150
City
Shakopee
State
MN
Zip/Postal Code
55379
Country
United States
Inspection Range
Sep 18, 2018 - Sep 20, 2018
Pages
6
First Observation
The device history record does not demonstrate that the device was manufactured in accordance with the device master record and 21 CFR 820.
Investigator(s): Marissa S. Steinhagen