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SHENTOU XIMONTH BIOTECHNOLOGY CO. LTD

⚠️ High Risk

FEI: 3040814475 • Shantou, Guangdong • CHINA

FEI

FEI Number

3040814475

📍

Location

Shantou, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Room 8 Floor 1, No 24 Hengshan Road Pujiang Road; Longhu District, Shantou, Guangdong, China

High Risk

FDA Import Risk Assessment

59.7
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

1
Total Refusals
1
Unique Violations
11/17/2025
Latest Refusal
11/17/2025
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
97.0×20%
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

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
11/17/2025
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHENTOU XIMONTH BIOTECHNOLOGY CO. LTD's FDA import refusal history?

SHENTOU XIMONTH BIOTECHNOLOGY CO. LTD (FEI: 3040814475) has 1 FDA import refusal record(s) in our database, spanning from 11/17/2025 to 11/17/2025.

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. SHENTOU XIMONTH BIOTECHNOLOGY CO. LTD's FEI number is 3040814475.

What types of violations has SHENTOU XIMONTH BIOTECHNOLOGY CO. LTD received?

SHENTOU XIMONTH BIOTECHNOLOGY 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 SHENTOU XIMONTH BIOTECHNOLOGY CO. LTD come from?

All FDA import refusal data for SHENTOU XIMONTH BIOTECHNOLOGY 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.