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JIANGXI SIMPLE & HONEST CO., LTD.

⚠️ Moderate Risk

FEI: 3013240115 • Jiujiang, Jiangxi • CHINA

FEI

FEI Number

3013240115

📍

Location

Jiujiang, Jiangxi

🇨🇳

Country

CHINA
🏢

Address

Chunqua, Shi Fangcun; Chunqiaoxiang Douchangxian, Jiujiang, Jiangxi, China

Moderate Risk

FDA Import Risk Assessment

38.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/31/2019
Latest Refusal
12/31/2019
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
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

1261×

FAILS STD

The article appears to be a device which is subject to a performance standard established under Section 514 and does not appear to be in all respects in conformity with such standard.

3441×

WARNINGS

It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.

Refusal History

DateProductViolationsDivision
12/31/2019
95RERALIGNMENT LASER PRODUCT, SURVEYING LEVELING, ALIGNMENT LASER PRODUCTS
126FAILS STD
344WARNINGS
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is JIANGXI SIMPLE & HONEST CO., LTD.'s FDA import refusal history?

JIANGXI SIMPLE & HONEST CO., LTD. (FEI: 3013240115) has 1 FDA import refusal record(s) in our database, spanning from 12/31/2019 to 12/31/2019.

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. JIANGXI SIMPLE & HONEST CO., LTD.'s FEI number is 3013240115.

What types of violations has JIANGXI SIMPLE & HONEST CO., LTD. received?

JIANGXI SIMPLE & HONEST 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 JIANGXI SIMPLE & HONEST CO., LTD. come from?

All FDA import refusal data for JIANGXI SIMPLE & HONEST 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.