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Wuhan Yuancheng Technology Development Co., Ltd.

⚠️ Moderate Risk

FEI: 3004683246 • Wuhan, Hubei • CHINA

FEI

FEI Number

3004683246

📍

Location

Wuhan, Hubei

🇨🇳

Country

CHINA
🏢

Address

496 Zhongshan Road, Wuchang, Wuhan, Hubei, China

Moderate Risk

FDA Import Risk Assessment

36.5
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
5/22/2012
Latest Refusal
4/20/2011
Earliest Refusal

Score Breakdown

Violation Severity
73.3×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
18.3×10%
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).

721×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

751×

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).

Refusal History

DateProductViolationsDivision
5/22/2012
56GAS20GRISEOFULVIN (ANTIFUNGAL)
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)
4/20/2011
62LOS40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL)
72NEW VET DR
New York District Office (NYK-DO)

Frequently Asked Questions

What is Wuhan Yuancheng Technology Development Co., Ltd.'s FDA import refusal history?

Wuhan Yuancheng Technology Development Co., Ltd. (FEI: 3004683246) has 2 FDA import refusal record(s) in our database, spanning from 4/20/2011 to 5/22/2012.

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. Wuhan Yuancheng Technology Development Co., Ltd.'s FEI number is 3004683246.

What types of violations has Wuhan Yuancheng Technology Development Co., Ltd. received?

Wuhan Yuancheng Technology Development 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 Wuhan Yuancheng Technology Development Co., Ltd. come from?

All FDA import refusal data for Wuhan Yuancheng Technology Development 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.