Source: FDA inspection record. Confirmed against FDA's published inspection data for this establishment and inspection date. FDA has published the inspection and what it cited, but not the form itself, which usually takes six to twelve months. To check it, open FDA's record for this establishment on FDA's Data Dashboard, listed under FEI 3003428492.
Observations5
Issue DateAugust 28, 2025
StatusNo Warning Letter
Related Inspections7
Establishment Details
Firm
Epien Medical, Inc
Location
White Bear Lake, Minnesota, United States
FEI Number
3003428492
Product Type
Drugs
Issue Date
August 28, 2025
Country
United States
Inspection History, 2009 to 2025
NAI3
VAI4
NAI means No Action Indicated. VAI means Voluntary Action Indicated.
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