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XIAMEN BAYSEN MEDI

⚠️ Moderate Risk

FEI: 3015558341 • Xiamen • CHINA

FEI

FEI Number

3015558341

📍

Location

Xiamen

🇨🇳

Country

CHINA
🏢

Address

UNIT 401, NO 1 JINZHONG ROAD, HULI DISTRICT, Xiamen, , China

Moderate Risk

FDA Import Risk Assessment

38.4
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

1
Total Refusals
1
Unique Violations
3/30/2022
Latest Refusal
3/30/2022
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
Refusal Volume
11.2×30%
Recency
10.2×20%
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

2371×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

DateProductViolationsDivision
3/30/2022
83QKOREAGENT, CORONAVIRUS SEROLOGICAL
237NO PMA
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is XIAMEN BAYSEN MEDI's FDA import refusal history?

XIAMEN BAYSEN MEDI (FEI: 3015558341) has 1 FDA import refusal record(s) in our database, spanning from 3/30/2022 to 3/30/2022.

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 BAYSEN MEDI's FEI number is 3015558341.

What types of violations has XIAMEN BAYSEN MEDI received?

XIAMEN BAYSEN MEDI 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 BAYSEN MEDI come from?

All FDA import refusal data for XIAMEN BAYSEN MEDI 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.