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Jiebao Daily Chemical (Xiangxi) Co., Ltd

Low Risk

FEI: 3016775836 • Xiang Xitu Jiazumiaozu Autonomous Prefecture, Hunan • CHINA

FEI

FEI Number

3016775836

📍

Location

Xiang Xitu Jiazumiaozu Autonomous Prefecture, Hunan

🇨🇳

Country

CHINA
🏢

Address

Building A Floor, 1 Standard Workshop; Industrial Development Zone, Xiang Xitu Jiazumiaozu Autonomous Prefecture, Hunan, China

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
8/6/2020
Latest Refusal
8/6/2020
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

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
8/6/2020
80QKRFACE MASK (EXCEPT N95 RESPIRATOR) FOR GENERAL PUBLIC/HEALTHCARE PERSONNEL PER IIE GUIDANCE
3280FRNMFGREG
341REGISTERED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is Jiebao Daily Chemical (Xiangxi) Co., Ltd's FDA import refusal history?

Jiebao Daily Chemical (Xiangxi) Co., Ltd (FEI: 3016775836) has 1 FDA import refusal record(s) in our database, spanning from 8/6/2020 to 8/6/2020.

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. Jiebao Daily Chemical (Xiangxi) Co., Ltd's FEI number is 3016775836.

What types of violations has Jiebao Daily Chemical (Xiangxi) Co., Ltd received?

Jiebao Daily Chemical (Xiangxi) 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 Jiebao Daily Chemical (Xiangxi) Co., Ltd come from?

All FDA import refusal data for Jiebao Daily Chemical (Xiangxi) 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.