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SHENYANG DELONG BR

⚠️ Moderate Risk

FEI: 3017886743 • Shenyang, Liaoning • CHINA

FEI

FEI Number

3017886743

📍

Location

Shenyang, Liaoning

🇨🇳

Country

CHINA
🏢

Address

4 Xita Street, Heping, Shenyang, Liaoning, China

Moderate Risk

FDA Import Risk Assessment

48.0
LowModerateHighCritical

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

Statistics

4
Total Refusals
2
Unique Violations
11/5/2021
Latest Refusal
11/5/2021
Earliest Refusal

Score Breakdown

Violation Severity
82.5×40%
Refusal Volume
25.9×30%
Recency
16.3×20%
Frequency
40.0×10%
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

2863×

POISON PKG

The article appears to be a drug and its packaging and labeling is in violation of an applicable regulation issued pursuant to section 3 or 4 of the Poison Prevention Packaging Act of 1970.

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
11/5/2021
66YDA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
286POISON PKG
Division of West Coast Imports (DWCI)
11/5/2021
66YDA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
286POISON PKG
Division of West Coast Imports (DWCI)
11/5/2021
66YDA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
286POISON PKG
Division of West Coast Imports (DWCI)
11/5/2021
66YDA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Division of West Coast Imports (DWCI)

Frequently Asked Questions

What is SHENYANG DELONG BR's FDA import refusal history?

SHENYANG DELONG BR (FEI: 3017886743) has 4 FDA import refusal record(s) in our database, spanning from 11/5/2021 to 11/5/2021.

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. SHENYANG DELONG BR's FEI number is 3017886743.

What types of violations has SHENYANG DELONG BR received?

SHENYANG DELONG BR has been cited for 2 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 SHENYANG DELONG BR come from?

All FDA import refusal data for SHENYANG DELONG BR 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.