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Jeijin Co Ltd

⚠️ Moderate Risk

FEI: 3010873998 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3010873998

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Block 6, Zone 3 Honghualing, Shenzhen, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
9/24/2020
Latest Refusal
9/24/2020
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
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

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).

4761×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

Refusal History

DateProductViolationsDivision
9/24/2020
95RHLLASER THERAPY PRODUCT
118NOT LISTED
476NO REGISTR
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is Jeijin Co Ltd's FDA import refusal history?

Jeijin Co Ltd (FEI: 3010873998) has 1 FDA import refusal record(s) in our database, spanning from 9/24/2020 to 9/24/2020.

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. Jeijin Co Ltd's FEI number is 3010873998.

What types of violations has Jeijin Co Ltd received?

Jeijin Co Ltd 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 Jeijin Co Ltd come from?

All FDA import refusal data for Jeijin Co Ltd 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.