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SHAOXING YOUGFENG SURGICAL DRESSING CO., LTD.

✅ Low Risk

FEI: 3006538152 • Shaoxing, Zhejiang • CHINA

FEI

FEI Number

3006538152

📍

Location

Shaoxing, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Fengcun, Doumen; Doumenzhen Yuechengjuwei Hui, Shaoxing, Zhejiang, China

Low Risk

FDA Import Risk Assessment

22.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
6/24/2014
Latest Refusal
6/24/2014
Earliest Refusal

Score Breakdown

Violation Severity
45.0×40%
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

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.

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

Refusal History

DateProductViolationsDivision
6/24/2014
80KGXTAPE AND BANDAGE, ADHESIVE
16DIRECTIONS
333LACKS FIRM
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is SHAOXING YOUGFENG SURGICAL DRESSING CO., LTD.'s FDA import refusal history?

SHAOXING YOUGFENG SURGICAL DRESSING CO., LTD. (FEI: 3006538152) has 1 FDA import refusal record(s) in our database, spanning from 6/24/2014 to 6/24/2014.

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. SHAOXING YOUGFENG SURGICAL DRESSING CO., LTD.'s FEI number is 3006538152.

What types of violations has SHAOXING YOUGFENG SURGICAL DRESSING CO., LTD. received?

SHAOXING YOUGFENG SURGICAL DRESSING 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 SHAOXING YOUGFENG SURGICAL DRESSING CO., LTD. come from?

All FDA import refusal data for SHAOXING YOUGFENG SURGICAL DRESSING 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.