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Sciclone Pharm Int'L Ltd

⚠️ Moderate Risk

FEI: 3004357582 • Hong Kong • HONG KONG

FEI

FEI Number

3004357582

📍

Location

Hong Kong

🇭🇰

Country

HONG KONG
🏢

Address

Room 3401a Windsor House, , Hong Kong, , Hong Kong

Moderate Risk

FDA Import Risk Assessment

43.0
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
10/30/2009
Latest Refusal
12/11/2007
Earliest Refusal

Score Breakdown

Violation Severity
86.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
15.9×10%
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

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).

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
10/30/2009
66VCP99MISCELLANEOUS PATENT MEDICINES, ETC.
27DRUG GMPS
Division of Southeast Imports (DSEI)
9/19/2008
62VCP99ANTI-VIRAL N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)
12/11/2007
64RCK99HORMONE N.E.C.
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Sciclone Pharm Int'L Ltd's FDA import refusal history?

Sciclone Pharm Int'L Ltd (FEI: 3004357582) has 3 FDA import refusal record(s) in our database, spanning from 12/11/2007 to 10/30/2009.

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. Sciclone Pharm Int'L Ltd's FEI number is 3004357582.

What types of violations has Sciclone Pharm Int'L Ltd received?

Sciclone Pharm Int'L 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 Sciclone Pharm Int'L Ltd come from?

All FDA import refusal data for Sciclone Pharm Int'L 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.