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Harbin Gelidai Cosmetics Company Lt

⚠️ Moderate Risk

FEI: 3006620696 • Nayuan • CHINA

FEI

FEI Number

3006620696

📍

Location

Nayuan

🇨🇳

Country

CHINA
🏢

Address

69 Erado St, , Nayuan, , China

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/10/2008
Latest Refusal
12/10/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
12/10/2008
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
San Francisco District Office (SAN-DO)

Frequently Asked Questions

What is Harbin Gelidai Cosmetics Company Lt's FDA import refusal history?

Harbin Gelidai Cosmetics Company Lt (FEI: 3006620696) has 1 FDA import refusal record(s) in our database, spanning from 12/10/2008 to 12/10/2008.

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. Harbin Gelidai Cosmetics Company Lt's FEI number is 3006620696.

What types of violations has Harbin Gelidai Cosmetics Company Lt received?

Harbin Gelidai Cosmetics Company Lt 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 Harbin Gelidai Cosmetics Company Lt come from?

All FDA import refusal data for Harbin Gelidai Cosmetics Company Lt 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.