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Zunan Commerce And Industrial Co Lt

⚠️ Moderate Risk

FEI: 3003307984 • Shenzhen • CHINA

FEI

FEI Number

3003307984

📍

Location

Shenzhen

🇨🇳

Country

CHINA
🏢

Address

United Plaza A 5022 Binhe Road Nort, , Shenzhen, , China

Moderate Risk

FDA Import Risk Assessment

32.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
2/17/2006
Latest Refusal
12/30/2002
Earliest Refusal

Score Breakdown

Violation Severity
66.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
6.4×10%
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).

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
2/17/2006
66CBY01DIOCTYL CALCIUM SULFOSUCCINATE (STOOL SOFTENER)
118NOT LISTED
16DIRECTIONS
New York District Office (NYK-DO)
12/30/2002
56YJS99ANTIBIOTIC N.E.C.
72NEW VET DR
New York District Office (NYK-DO)

Frequently Asked Questions

What is Zunan Commerce And Industrial Co Lt's FDA import refusal history?

Zunan Commerce And Industrial Co Lt (FEI: 3003307984) has 2 FDA import refusal record(s) in our database, spanning from 12/30/2002 to 2/17/2006.

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. Zunan Commerce And Industrial Co Lt's FEI number is 3003307984.

What types of violations has Zunan Commerce And Industrial Co Lt received?

Zunan Commerce And Industrial Co Lt 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 Zunan Commerce And Industrial Co Lt come from?

All FDA import refusal data for Zunan Commerce And Industrial Co Lt 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.