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Yiwu jiangr Bio-technology Co.,Ltd

⚠️ Moderate Risk

FEI: 3009802891 • Yiwu, Zhejiang • CHINA

FEI

FEI Number

3009802891

📍

Location

Yiwu, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

No 669 Chanhua Road, Fotang Industry Area, Yiwu, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

40.7
LowModerateHighCritical

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

Statistics

5
Total Refusals
3
Unique Violations
2/10/2011
Latest Refusal
3/25/2005
Earliest Refusal

Score Breakdown

Violation Severity
78.0×40%
Refusal Volume
28.8×30%
Recency
0.0×20%
Frequency
8.5×10%
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

753×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

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).

161×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

Refusal History

DateProductViolationsDivision
2/10/2011
02CGH99RICE FLOUR, N.E.C.
118NOT LISTED
Los Angeles District Office (LOS-DO)
1/10/2007
61JCR99ANTI-CHOLESTEREMIC, N.E.C.
16DIRECTIONS
Seattle District Office (SEA-DO)
4/4/2005
61JAY99ANTI-CHOLESTEREMIC, N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
3/28/2005
66VBS99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
3/25/2005
66VBR99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Yiwu jiangr Bio-technology Co.,Ltd's FDA import refusal history?

Yiwu jiangr Bio-technology Co.,Ltd (FEI: 3009802891) has 5 FDA import refusal record(s) in our database, spanning from 3/25/2005 to 2/10/2011.

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 jiangr Bio-technology Co.,Ltd's FEI number is 3009802891.

What types of violations has Yiwu jiangr Bio-technology Co.,Ltd received?

Yiwu jiangr Bio-technology Co.,Ltd has been cited for 3 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 jiangr Bio-technology Co.,Ltd come from?

All FDA import refusal data for Yiwu jiangr Bio-technology 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.