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Hart Enterprises Inc.

✅ Low Risk

FEI: 1828424 • Sparta, MI • UNITED STATES

FEI

FEI Number

1828424

📍

Location

Sparta, MI

🇺🇸
🏢

Address

400 Apple Jack Ct, , Sparta, MI, United States

Low Risk

FDA Import Risk Assessment

16.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
1
Unique Violations
11/14/2006
Latest Refusal
11/14/2006
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
11/14/2006
84GXDGENERATOR, LESION, RADIOFREQUENCY
341REGISTERED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Hart Enterprises Inc.'s FDA import refusal history?

Hart Enterprises Inc. (FEI: 1828424) has 1 FDA import refusal record(s) in our database, spanning from 11/14/2006 to 11/14/2006.

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. Hart Enterprises Inc.'s FEI number is 1828424.

What types of violations has Hart Enterprises Inc. received?

Hart Enterprises 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 Hart Enterprises Inc. come from?

All FDA import refusal data for Hart Enterprises 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.