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Lake Region Manufacturing, Inc

✅ Low Risk

FEI: 2126666 • Chaska, MN • UNITED STATES

FEI

FEI Number

2126666

📍

Location

Chaska, MN

🇺🇸
🏢

Address

340 Lake Hazeltine Dr, , Chaska, MN, 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
6/3/2019
Latest Refusal
6/3/2019
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
6/3/2019
74NTECATHETER, CAROTID, TEMPORARY, FOR EMBOLIZATION CAPTURE
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Lake Region Manufacturing, Inc's FDA import refusal history?

Lake Region Manufacturing, Inc (FEI: 2126666) has 1 FDA import refusal record(s) in our database, spanning from 6/3/2019 to 6/3/2019.

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. Lake Region Manufacturing, Inc's FEI number is 2126666.

What types of violations has Lake Region Manufacturing, Inc received?

Lake Region Manufacturing, 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 Lake Region Manufacturing, Inc come from?

All FDA import refusal data for Lake Region Manufacturing, 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.