ImportRefusal LogoImportRefusal

Ganzhou Olivee Cosmetic Co., Ltd.

⚠️ Moderate Risk

FEI: 3006653048 • Ganzhou, Jiangxi • CHINA

FEI

FEI Number

3006653048

📍

Location

Ganzhou, Jiangxi

🇨🇳

Country

CHINA
🏢

Address

Hongjin Gongyeyuan, No.11 Huoju Road; Ganxian, Ganzhou, Jiangxi, China

Moderate Risk

FDA Import Risk Assessment

31.8
LowModerateHighCritical

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

Statistics

4
Total Refusals
1
Unique Violations
11/23/2016
Latest Refusal
11/23/2016
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

1184×

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).

Refusal History

DateProductViolationsDivision
11/23/2016
55PY24TRIETHANOLAMINE (PHARMACEUTIC NECESSITY)
118NOT LISTED
Los Angeles District Office (LOS-DO)
11/23/2016
55PY24TRIETHANOLAMINE (PHARMACEUTIC NECESSITY)
118NOT LISTED
Los Angeles District Office (LOS-DO)
11/23/2016
55PY24TRIETHANOLAMINE (PHARMACEUTIC NECESSITY)
118NOT LISTED
Los Angeles District Office (LOS-DO)
11/23/2016
55PY24TRIETHANOLAMINE (PHARMACEUTIC NECESSITY)
118NOT LISTED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Ganzhou Olivee Cosmetic Co., Ltd.'s FDA import refusal history?

Ganzhou Olivee Cosmetic Co., Ltd. (FEI: 3006653048) has 4 FDA import refusal record(s) in our database, spanning from 11/23/2016 to 11/23/2016.

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. Ganzhou Olivee Cosmetic Co., Ltd.'s FEI number is 3006653048.

What types of violations has Ganzhou Olivee Cosmetic Co., Ltd. received?

Ganzhou Olivee Cosmetic Co., 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 Ganzhou Olivee Cosmetic Co., Ltd. come from?

All FDA import refusal data for Ganzhou Olivee Cosmetic 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.