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Sunbay Supplies China Co Ltd

✅ Low Risk

FEI: 3006373327 • Zhangqiu • CHINA

FEI

FEI Number

3006373327

📍

Location

Zhangqiu

🇨🇳

Country

CHINA
🏢

Address

401 Unit A Baimeiquan Business, , Zhangqiu, , China

Low Risk

FDA Import Risk Assessment

18.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
2/13/2008
Latest Refusal
2/13/2008
Earliest Refusal

Score Breakdown

Violation Severity
35.0×40%
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

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).

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
2/13/2008
76NXZKIT, DENTAL HYGIENE
118NOT LISTED
333LACKS FIRM
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Sunbay Supplies China Co Ltd's FDA import refusal history?

Sunbay Supplies China Co Ltd (FEI: 3006373327) has 1 FDA import refusal record(s) in our database, spanning from 2/13/2008 to 2/13/2008.

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. Sunbay Supplies China Co Ltd's FEI number is 3006373327.

What types of violations has Sunbay Supplies China Co Ltd received?

Sunbay Supplies China 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 Sunbay Supplies China Co Ltd come from?

All FDA import refusal data for Sunbay Supplies China 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.