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Epien Medical, Inc. - Dec. 6, 2018

Issue Date

Dec 06, 2018

Region

Central

Category

Drug
$117.00

Epien Medical, Inc.

Contact Name

Reginald R. Dupre

Contact Title

Chief Executive Officer

Form483 Address 1

4225 White Bear Pkwy.

Form483 Address 2

Ste. 600

Form483 City

White Bear Lake

Form483 State

MN

Form483 Postal

55110-3389

Form483 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