Epien Medical, Inc. - Dec. 6, 2018
Issue Date
Dec 06, 2018
Region
Central
Category
Drug
$117.00
Contact Name
Reginald R. Dupre
Contact Title
Chief Executive Officer
Address 1
4225 White Bear Pkwy.
Address 2
Ste. 600
City
White Bear Lake
State
MN
Zip/Postal Code
55110-3389
Country
United States
Inspection Range
Nov 26, 2018 - Dec 06, 2018
Pages
2
First Observation
Reports of analysis from component suppliers are accepted in lieu of testing each component for
conformity with all appropriate written specifications, without establishing the reliability of the
supplier's analyses through appropriate validation of the supplier's test results at appropriate intervals.
Investigator(s): James K. Ireland