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Zhejiang Huali Fashion Co. Ltd.

⚠️ Moderate Risk

FEI: 3005765470 • Hangzhou, Zhejiang • CHINA

FEI

FEI Number

3005765470

📍

Location

Hangzhou, Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Qian Wang St., Linpingzhen Yuhang District, Hangzhou, Zhejiang, China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/29/2014
Latest Refusal
12/29/2014
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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.

Refusal History

DateProductViolationsDivision
12/29/2014
62VDY34NEVIRAPINE (ANTI-VIRAL)
16DIRECTIONS
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Zhejiang Huali Fashion Co. Ltd.'s FDA import refusal history?

Zhejiang Huali Fashion Co. Ltd. (FEI: 3005765470) has 1 FDA import refusal record(s) in our database, spanning from 12/29/2014 to 12/29/2014.

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. Zhejiang Huali Fashion Co. Ltd.'s FEI number is 3005765470.

What types of violations has Zhejiang Huali Fashion Co. Ltd. received?

Zhejiang Huali Fashion 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 Zhejiang Huali Fashion Co. Ltd. come from?

All FDA import refusal data for Zhejiang Huali Fashion 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.