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Hung Sen Fuh Enterprise Co Ltd

⚠️ Moderate Risk

FEI: 3006479772 • Chang Hwa Hsienchang Hwa Hsien • TAIWAN

FEI

FEI Number

3006479772

📍

Location

Chang Hwa Hsienchang Hwa Hsien

🇹🇼

Country

TAIWAN
🏢

Address

No 9 Alley 28 Fute Lane Yungchunvillage, , Chang Hwa Hsienchang Hwa Hsien, , Taiwan

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/26/2007
Latest Refusal
10/26/2007
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

4721×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

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
10/26/2007
66VCA99MISCELLANEOUS PATENT MEDICINES, ETC.
472NO ENGLISH
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Hung Sen Fuh Enterprise Co Ltd's FDA import refusal history?

Hung Sen Fuh Enterprise Co Ltd (FEI: 3006479772) has 1 FDA import refusal record(s) in our database, spanning from 10/26/2007 to 10/26/2007.

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. Hung Sen Fuh Enterprise Co Ltd's FEI number is 3006479772.

What types of violations has Hung Sen Fuh Enterprise Co Ltd received?

Hung Sen Fuh Enterprise 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 Hung Sen Fuh Enterprise Co Ltd come from?

All FDA import refusal data for Hung Sen Fuh Enterprise 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.