ImportRefusal LogoImportRefusal

HENAN FENGTAI INDUSTRY&COMMERCE LTD.

⚠️ Moderate Risk

FEI: 2000036347 • Zhengzhou, Henan • CHINA

FEI

FEI Number

2000036347

📍

Location

Zhengzhou, Henan

🇨🇳

Country

CHINA
🏢

Address

Mazhai Industrial Park., No. 20 Xianfeng Road, Zhengzhou, Henan, China

Moderate Risk

FDA Import Risk Assessment

46.3
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
6/1/2010
Latest Refusal
10/22/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
24.9×10%
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

754×

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
6/1/2010
66SBA51TADALAFIL
75UNAPPROVED
Los Angeles District Office (LOS-DO)
10/22/2008
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
10/22/2008
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
10/22/2008
54YCY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is HENAN FENGTAI INDUSTRY&COMMERCE LTD.'s FDA import refusal history?

HENAN FENGTAI INDUSTRY&COMMERCE LTD. (FEI: 2000036347) has 4 FDA import refusal record(s) in our database, spanning from 10/22/2008 to 6/1/2010.

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. HENAN FENGTAI INDUSTRY&COMMERCE LTD.'s FEI number is 2000036347.

What types of violations has HENAN FENGTAI INDUSTRY&COMMERCE LTD. received?

HENAN FENGTAI INDUSTRY&COMMERCE LTD. has been cited for 1 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 HENAN FENGTAI INDUSTRY&COMMERCE LTD. come from?

All FDA import refusal data for HENAN FENGTAI INDUSTRY&COMMERCE 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.