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Zhejiang Hongyu Import

⚠️ Moderate Risk

FEI: 3005628453 • Zhejiang • CHINA

FEI

FEI Number

3005628453

📍

Location

Zhejiang

🇨🇳

Country

CHINA
🏢

Address

828 Double Dragon Road, , Zhejiang, , China

Moderate Risk

FDA Import Risk Assessment

38.1
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
4/10/2007
Latest Refusal
12/7/2006
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

1185×

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).

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
4/10/2007
56GYQ99ANTIFUNGAL N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
12/7/2006
62SBL99ANTI-SEBORRHEIC N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
12/7/2006
62WBJ99ASTRINGENT/ANTI-PERSPIRANT N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
12/7/2006
62WBJ99ASTRINGENT/ANTI-PERSPIRANT N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
12/7/2006
62WBJ99ASTRINGENT/ANTI-PERSPIRANT N.E.C.
118NOT LISTED
New York District Office (NYK-DO)
12/7/2006
62WDJ99ASTRINGENT/ANTI-PERSPIRANT N.E.C.
118NOT LISTED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Zhejiang Hongyu Import's FDA import refusal history?

Zhejiang Hongyu Import (FEI: 3005628453) has 6 FDA import refusal record(s) in our database, spanning from 12/7/2006 to 4/10/2007.

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 Hongyu Import's FEI number is 3005628453.

What types of violations has Zhejiang Hongyu Import received?

Zhejiang Hongyu Import 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 Zhejiang Hongyu Import come from?

All FDA import refusal data for Zhejiang Hongyu Import 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.