ImportRefusal LogoImportRefusal

Epien Medical, Inc

⚠️ Moderate Risk

FEI: 3003428492 • White Bear Lake, MN • UNITED STATES

FEI

FEI Number

3003428492

📍

Location

White Bear Lake, MN

🇺🇸
🏢

Address

4225 White Bear Pkwy Ste 600, , White Bear Lake, MN, United States

Moderate Risk

FDA Import Risk Assessment

41.5
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
1/4/2022
Latest Refusal
1/4/2022
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
5.6×20%
Frequency
10.0×10%
How is this score calculated?

Proprietary Algorithm

  • 40% Violation Severity — AI-assessed (1-10)
  • 30% Refusal Volume — Logarithmic scale
  • 20% Recency — Decays over 5 years
  • 10% Frequency — Refusals per year

© ImportRefusal.com Original Analysis

Violation Summary

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
1/4/2022
60QCY56BENZOCAINE (ANESTHETIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Epien Medical, Inc's FDA import refusal history?

Epien Medical, Inc (FEI: 3003428492) has 1 FDA import refusal record(s) in our database, spanning from 1/4/2022 to 1/4/2022.

What is an FEI number?

FEI stands for Firm Establishment Identifier. It's a unique number assigned by the FDA to identify establishments that manufacture, process, pack, or hold food, drugs, medical devices, or other FDA-regulated products. Epien Medical, Inc's FEI number is 3003428492.

What types of violations has Epien Medical, Inc received?

Epien Medical, Inc has been cited for 1 different violation type(s). Common FDA violations include adulteration (unsafe or unsanitary products), misbranding (incorrect or misleading labels), and regulatory non-compliance.

Where does this information about Epien Medical, Inc come from?

All FDA import refusal data for Epien Medical, Inc is sourced from the official FDA Data Dashboard (datadashboard.fda.gov), a public government database maintained by the U.S. Food and Drug Administration.

Data sourced from the FDA Data Dashboard, a public database maintained by the U.S. Food and Drug Administration.