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Hangzhou Longsheng Industrial Trading Co

⚠️ Moderate Risk

FEI: 3007530646 • Zhejiang • CHINA

FEI

FEI Number

3007530646

📍

Location

Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Dongzhou Industrial Park Dongzhou, , Zhejiang, , China

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
2/22/2010
Latest Refusal
2/22/2010
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

1182×

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).

752×

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
2/22/2010
61LSC08HEPARIN SODIUM (ANTI-COAGULANT)
118NOT LISTED
75UNAPPROVED
Chicago District Office (CHI-DO)
2/22/2010
55RC75CRUDE HEPARIN (PHARMACEUTIC NECESSITY)
118NOT LISTED
75UNAPPROVED
Chicago District Office (CHI-DO)

Frequently Asked Questions

What is Hangzhou Longsheng Industrial Trading Co's FDA import refusal history?

Hangzhou Longsheng Industrial Trading Co (FEI: 3007530646) has 2 FDA import refusal record(s) in our database, spanning from 2/22/2010 to 2/22/2010.

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. Hangzhou Longsheng Industrial Trading Co's FEI number is 3007530646.

What types of violations has Hangzhou Longsheng Industrial Trading Co received?

Hangzhou Longsheng Industrial Trading Co 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 Hangzhou Longsheng Industrial Trading Co come from?

All FDA import refusal data for Hangzhou Longsheng Industrial Trading Co 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.