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XIAMEN TOPLINK CRAFT CO., LTD.

✅ Low Risk

FEI: 3012918551 • Xiamen • CHINA

FEI

FEI Number

3012918551

📍

Location

Xiamen

🇨🇳

Country

CHINA
🏢

Address

Rm. 602, NO. 636 2nd R; Tong'An District, Xiamen, , 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

1
Total Refusals
3
Unique Violations
10/27/2017
Latest Refusal
10/27/2017
Earliest Refusal

Score Breakdown

Violation Severity
43.3×40%
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).

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

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
10/27/2017
86HQYSUNGLASSES (NON-PRESCRIPTION INCLUDING PHOTOSENSITIVE)
118NOT LISTED
3280FRNMFGREG
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is XIAMEN TOPLINK CRAFT CO., LTD.'s FDA import refusal history?

XIAMEN TOPLINK CRAFT CO., LTD. (FEI: 3012918551) has 1 FDA import refusal record(s) in our database, spanning from 10/27/2017 to 10/27/2017.

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 TOPLINK CRAFT CO., LTD.'s FEI number is 3012918551.

What types of violations has XIAMEN TOPLINK CRAFT CO., LTD. received?

XIAMEN TOPLINK CRAFT CO., LTD. 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 XIAMEN TOPLINK CRAFT CO., LTD. come from?

All FDA import refusal data for XIAMEN TOPLINK CRAFT 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.