ImportRefusal LogoImportRefusal

SHENZHEN SHIFEIKOU BIOTECHNOLOGYCO

⚠️ High Risk

FEI: 3030547866 • Shenzhen, Guangdong • CHINA

FEI

FEI Number

3030547866

📍

Location

Shenzhen, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Shenzhen, 804 805 Wuye Dasha Zone44 Anle Com Baoan, Shenzhen, Guangdong, China

High Risk

FDA Import Risk Assessment

54.6
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
8/9/2024
Latest Refusal
8/9/2024
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
71.2×20%
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

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
8/9/2024
65RAY10MAGNESIUM CHLORIDE (REPLENISHER)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SHENZHEN SHIFEIKOU BIOTECHNOLOGYCO's FDA import refusal history?

SHENZHEN SHIFEIKOU BIOTECHNOLOGYCO (FEI: 3030547866) has 1 FDA import refusal record(s) in our database, spanning from 8/9/2024 to 8/9/2024.

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. SHENZHEN SHIFEIKOU BIOTECHNOLOGYCO's FEI number is 3030547866.

What types of violations has SHENZHEN SHIFEIKOU BIOTECHNOLOGYCO received?

SHENZHEN SHIFEIKOU BIOTECHNOLOGYCO 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 SHENZHEN SHIFEIKOU BIOTECHNOLOGYCO come from?

All FDA import refusal data for SHENZHEN SHIFEIKOU BIOTECHNOLOGYCO 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.