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YIWU KEBON HEALTHCARE CO., LTD.

⚠️ High Risk

FEI: 3030017177 • Jinhua, Zhejiang • CHINA

FEI

FEI Number

3030017177

📍

Location

Jinhua, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Yongmao Road, 201 Choujiang Street; Yiwu, Jinhua, Zhejiang, China

High Risk

FDA Import Risk Assessment

50.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
8/23/2024
Latest Refusal
8/23/2024
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
72.0×20%
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

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
8/23/2024
66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Northern Border Imports (DNBI)

Frequently Asked Questions

What is YIWU KEBON HEALTHCARE CO., LTD.'s FDA import refusal history?

YIWU KEBON HEALTHCARE CO., LTD. (FEI: 3030017177) has 1 FDA import refusal record(s) in our database, spanning from 8/23/2024 to 8/23/2024.

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. YIWU KEBON HEALTHCARE CO., LTD.'s FEI number is 3030017177.

What types of violations has YIWU KEBON HEALTHCARE CO., LTD. received?

YIWU KEBON HEALTHCARE CO., LTD. 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 YIWU KEBON HEALTHCARE CO., LTD. come from?

All FDA import refusal data for YIWU KEBON HEALTHCARE 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.