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XIAMEN AQUATOWN TECHNOLOGY CO LTD

Low Risk

FEI: 3015335961 • Xiamen, Fujian • CHINA

FEI

FEI Number

3015335961

📍

Location

Xiamen, Fujian

🇨🇳

Country

CHINA
🏢

Address

4th Floor, , Xiamen, Fujian, China

Low Risk

FDA Import Risk Assessment

24.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
7/13/2021
Latest Refusal
7/13/2021
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
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).

Refusal History

DateProductViolationsDivision
7/13/2021
85OHHBREAST PUMP KIT
118NOT LISTED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is XIAMEN AQUATOWN TECHNOLOGY CO LTD's FDA import refusal history?

XIAMEN AQUATOWN TECHNOLOGY CO LTD (FEI: 3015335961) has 1 FDA import refusal record(s) in our database, spanning from 7/13/2021 to 7/13/2021.

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 AQUATOWN TECHNOLOGY CO LTD's FEI number is 3015335961.

What types of violations has XIAMEN AQUATOWN TECHNOLOGY CO LTD received?

XIAMEN AQUATOWN TECHNOLOGY CO LTD 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 XIAMEN AQUATOWN TECHNOLOGY CO LTD come from?

All FDA import refusal data for XIAMEN AQUATOWN TECHNOLOGY 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.