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Sha Hongzhuangyuan Intl Co Ltd

⚠️ Moderate Risk

FEI: 3010068071 • Shanghaishanghai • CHINA

FEI

FEI Number

3010068071

📍

Location

Shanghaishanghai

🇨🇳

Country

CHINA
🏢

Address

Rm.1501 No.14 Champs Elyses Garden, , Shanghaishanghai, , China

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
4/15/2013
Latest Refusal
4/15/2013
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

1181×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

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
4/15/2013
66BBK44NICOTINE DELIVERY SYSTEM
118NOT LISTED
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Sha Hongzhuangyuan Intl Co Ltd's FDA import refusal history?

Sha Hongzhuangyuan Intl Co Ltd (FEI: 3010068071) has 1 FDA import refusal record(s) in our database, spanning from 4/15/2013 to 4/15/2013.

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. Sha Hongzhuangyuan Intl Co Ltd's FEI number is 3010068071.

What types of violations has Sha Hongzhuangyuan Intl Co Ltd received?

Sha Hongzhuangyuan Intl Co Ltd 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 Sha Hongzhuangyuan Intl Co Ltd come from?

All FDA import refusal data for Sha Hongzhuangyuan Intl 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.