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Mentholatum (China) Pharmaceuticals Co., Ltd.

⚠️ Moderate Risk

FEI: 3000188423 • Zhongshan, Guangdong • CHINA

FEI

FEI Number

3000188423

📍

Location

Zhongshan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Second Industrial Zone, Sanxiang Town, , Zhongshan, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

38.4
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
9/19/2023
Latest Refusal
2/9/2005
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
17.7×30%
Recency
38.5×20%
Frequency
1.1×10%
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

1182×

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).

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
9/19/2023
60CBK46NAPHAZOLINE HCL (ADRENERGIC)
118NOT LISTED
Division of Northeast Imports (DNEI)
2/9/2005
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is Mentholatum (China) Pharmaceuticals Co., Ltd.'s FDA import refusal history?

Mentholatum (China) Pharmaceuticals Co., Ltd. (FEI: 3000188423) has 2 FDA import refusal record(s) in our database, spanning from 2/9/2005 to 9/19/2023.

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. Mentholatum (China) Pharmaceuticals Co., Ltd.'s FEI number is 3000188423.

What types of violations has Mentholatum (China) Pharmaceuticals Co., Ltd. received?

Mentholatum (China) Pharmaceuticals 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 Mentholatum (China) Pharmaceuticals Co., Ltd. come from?

All FDA import refusal data for Mentholatum (China) Pharmaceuticals 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.