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KUNSHAN HEALTH & BEYOND

✅ Low Risk

FEI: 3012676009 • Kunshan • CHINA

FEI

FEI Number

3012676009

📍

Location

Kunshan

🇨🇳

Country

CHINA
🏢

Address

Bldg ROOM 1611, 2 Lane, Kunshan, , China

Low Risk

FDA Import Risk Assessment

21.7
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
10/20/2020
Latest Refusal
10/19/2020
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

38733×

708NOREG

It has been determined the drug was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
10/20/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
3873708NOREG
Division of Northeast Imports (DNEI)
10/20/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
3873708NOREG
Division of Northeast Imports (DNEI)
10/19/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
3873708NOREG
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is KUNSHAN HEALTH & BEYOND's FDA import refusal history?

KUNSHAN HEALTH & BEYOND (FEI: 3012676009) has 3 FDA import refusal record(s) in our database, spanning from 10/19/2020 to 10/20/2020.

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. KUNSHAN HEALTH & BEYOND's FEI number is 3012676009.

What types of violations has KUNSHAN HEALTH & BEYOND received?

KUNSHAN HEALTH & BEYOND 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 KUNSHAN HEALTH & BEYOND come from?

All FDA import refusal data for KUNSHAN HEALTH & BEYOND 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.