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HEARS HEARING & HEARABLES

⚠️ Moderate Risk

FEI: 3032145641 • Hopkins, MN • UNITED STATES

FEI

FEI Number

3032145641

📍

Location

Hopkins, MN

🇺🇸
🏢

Address

11 10th Ave S Ste A, , Hopkins, MN, United States

Moderate Risk

FDA Import Risk Assessment

39.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
10/9/2024
Latest Refusal
10/9/2024
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
74.6×20%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
10/9/2024
77OSMHEARING AID, AIR CONDUCTION WITH WIRELESS TECHNOLOGY
3280FRNMFGREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is HEARS HEARING & HEARABLES's FDA import refusal history?

HEARS HEARING & HEARABLES (FEI: 3032145641) has 1 FDA import refusal record(s) in our database, spanning from 10/9/2024 to 10/9/2024.

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. HEARS HEARING & HEARABLES's FEI number is 3032145641.

What types of violations has HEARS HEARING & HEARABLES received?

HEARS HEARING & HEARABLES 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 HEARS HEARING & HEARABLES come from?

All FDA import refusal data for HEARS HEARING & HEARABLES 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.