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HANGZHOU DAYANGCHEM CO LTD

⚠️ Moderate Risk

FEI: 3012465094 • Hangzhou • CHINA

FEI

FEI Number

3012465094

📍

Location

Hangzhou

🇨🇳

Country

CHINA
🏢

Address

259 Wensan Rd, Xihu Dist, Hangzhou, , China

Moderate Risk

FDA Import Risk Assessment

34.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
7/23/2015
Latest Refusal
7/23/2015
Earliest Refusal

Score Breakdown

Violation Severity
75.0×40%
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.

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.

Refusal History

DateProductViolationsDivision
7/23/2015
56YXY99ANTIBIOTIC N.E.C.
16DIRECTIONS
72NEW VET DR
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is HANGZHOU DAYANGCHEM CO LTD's FDA import refusal history?

HANGZHOU DAYANGCHEM CO LTD (FEI: 3012465094) has 1 FDA import refusal record(s) in our database, spanning from 7/23/2015 to 7/23/2015.

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. HANGZHOU DAYANGCHEM CO LTD's FEI number is 3012465094.

What types of violations has HANGZHOU DAYANGCHEM CO LTD received?

HANGZHOU DAYANGCHEM 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 HANGZHOU DAYANGCHEM CO LTD come from?

All FDA import refusal data for HANGZHOU DAYANGCHEM 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.