Home / Facilities / 3003428492

EPIEN Medical, Inc. — FDA Facility Profile

FEI 3003428492

EPIEN Medical, Inc. is an FDA-registered facility (FEI 3003428492) located in White Bear Lake, MN, US. Registered operations: MANUFACTURE. RegDataLab tracks 7 FDA inspections at this facility.

Facility Details

Location
White Bear Lake, MN (US)
Registration Expires
December 31, 2026
Operations
MANUFACTURE
Source
both

Recent inspections

  • 1280917 (VAI Thu Aug 28 2025 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1247073 (NAI Tue Aug 06 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1073560 (VAI Thu Dec 06 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1072268 (NAI Thu Nov 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 859099 (VAI Wed Dec 11 2013 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 730791 (NAI Wed Jun 15 2011 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 616289 (VAI Tue Sep 29 2009 00:00:00 GMT+0000 (Coordinated Universal Time))

Import refusals

  • 799-6531869-3/21/1 (Tue Jan 04 2022 00:00:00 GMT+0000 (Coordinated Universal Time) — Drugs and Biologics)

FDA data resources