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SHANGHAI BASIC UNION HEALTHY IND

⚠️ Moderate Risk

FEI: 3013132916 • SHANGHAI • CHINA

FEI

FEI Number

3013132916

📍

Location

SHANGHAI

🇨🇳

Country

CHINA
🏢

Address

NO. 360 CENTURY AVENUE, , SHANGHAI, , China

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
3/13/2017
Latest Refusal
3/13/2017
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
3/13/2017
54YCA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is SHANGHAI BASIC UNION HEALTHY IND's FDA import refusal history?

SHANGHAI BASIC UNION HEALTHY IND (FEI: 3013132916) has 1 FDA import refusal record(s) in our database, spanning from 3/13/2017 to 3/13/2017.

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. SHANGHAI BASIC UNION HEALTHY IND's FEI number is 3013132916.

What types of violations has SHANGHAI BASIC UNION HEALTHY IND received?

SHANGHAI BASIC UNION HEALTHY IND 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 SHANGHAI BASIC UNION HEALTHY IND come from?

All FDA import refusal data for SHANGHAI BASIC UNION HEALTHY IND 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.