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JKM INTERNATIONAL, INC.

✅ Low Risk

FEI: 3007582661 • Dongguan, Guangdong • CHINA

FEI

FEI Number

3007582661

📍

Location

Dongguan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Beiyuan 2nd Road, Lianhu Second Industrial, 3rd-4th Floor, Jinhang Technology Compound, No. 2; Lianhu Guanli Tangshazhen, Dongguan, Guangdong, China

Low Risk

FDA Import Risk Assessment

21.2
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/9/2021
Latest Refusal
12/9/2021
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
Refusal Volume
11.2×30%
Recency
4.2×20%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

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
12/9/2021
89ILOPACK, HOT OR COLD, WATER CIRCULATING
118NOT LISTED
341REGISTERED
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is JKM INTERNATIONAL, INC.'s FDA import refusal history?

JKM INTERNATIONAL, INC. (FEI: 3007582661) has 1 FDA import refusal record(s) in our database, spanning from 12/9/2021 to 12/9/2021.

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. JKM INTERNATIONAL, INC.'s FEI number is 3007582661.

What types of violations has JKM INTERNATIONAL, INC. received?

JKM INTERNATIONAL, INC. has been cited for 2 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 JKM INTERNATIONAL, INC. come from?

All FDA import refusal data for JKM INTERNATIONAL, 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.