ImportRefusal LogoImportRefusal

Xiamen Yizhou Imp. & Exp. Co. Ltd.

✅ Low Risk

FEI: 3008763803 • Xiamen, Fujian • CHINA

FEI

FEI Number

3008763803

📍

Location

Xiamen, Fujian

🇨🇳

Country

CHINA
🏢

Address

Huli Industrial Park F 2, Meixi Rd.; Tong An District, Xiamen, Fujian, China

Low Risk

FDA Import Risk Assessment

19.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/16/2022
Latest Refusal
8/16/2022
Earliest Refusal

Score Breakdown

Violation Severity
30.0×40%
Refusal Volume
11.2×30%
Recency
17.9×20%
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

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
8/16/2022
76LRKDEVICE, ANTI-SNORING
341REGISTERED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Xiamen Yizhou Imp. & Exp. Co. Ltd.'s FDA import refusal history?

Xiamen Yizhou Imp. & Exp. Co. Ltd. (FEI: 3008763803) has 1 FDA import refusal record(s) in our database, spanning from 8/16/2022 to 8/16/2022.

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 Yizhou Imp. & Exp. Co. Ltd.'s FEI number is 3008763803.

What types of violations has Xiamen Yizhou Imp. & Exp. Co. Ltd. received?

Xiamen Yizhou Imp. & Exp. 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 Yizhou Imp. & Exp. Co. Ltd. come from?

All FDA import refusal data for Xiamen Yizhou Imp. & Exp. 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.