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XIAMEN BMT TRADING CO., LTD.

✅ Low Risk

FEI: 3012730468 • Xiamen, Fujian • CHINA

FEI

FEI Number

3012730468

📍

Location

Xiamen, Fujian

🇨🇳

Country

CHINA
🏢

Address

Siming, Qixing West Rd, Xiamen, Fujian, China

Low Risk

FDA Import Risk Assessment

20.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/4/2016
Latest Refusal
10/4/2016
Earliest Refusal

Score Breakdown

Violation Severity
40.0×40%
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).

3411×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

Refusal History

DateProductViolationsDivision
10/4/2016
76LQZDEVICE, JAW REPOSITIONING
118NOT LISTED
341REGISTERED
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is XIAMEN BMT TRADING CO., LTD.'s FDA import refusal history?

XIAMEN BMT TRADING CO., LTD. (FEI: 3012730468) has 1 FDA import refusal record(s) in our database, spanning from 10/4/2016 to 10/4/2016.

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. XIAMEN BMT TRADING CO., LTD.'s FEI number is 3012730468.

What types of violations has XIAMEN BMT TRADING CO., LTD. received?

XIAMEN BMT TRADING 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 XIAMEN BMT TRADING CO., LTD. come from?

All FDA import refusal data for XIAMEN BMT TRADING 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.