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Huang Mei County Minda Foreign Trade Co.

⚠️ Moderate Risk

FEI: 3004877002 • Zhejiang • CHINA

FEI

FEI Number

3004877002

📍

Location

Zhejiang

🇨🇳

Country

CHINA
🏢

Address

Street No. 499-7 Chouzhou North Road, , Zhejiang, , China

Moderate Risk

FDA Import Risk Assessment

35.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
11/1/2005
Latest Refusal
11/1/2005
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
20.0×10%
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

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).

752×

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
11/1/2005
63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
75UNAPPROVED
Florida District Office (FLA-DO)
11/1/2005
63RBY05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC)
118NOT LISTED
75UNAPPROVED
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Huang Mei County Minda Foreign Trade Co.'s FDA import refusal history?

Huang Mei County Minda Foreign Trade Co. (FEI: 3004877002) has 2 FDA import refusal record(s) in our database, spanning from 11/1/2005 to 11/1/2005.

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. Huang Mei County Minda Foreign Trade Co.'s FEI number is 3004877002.

What types of violations has Huang Mei County Minda Foreign Trade Co. received?

Huang Mei County Minda Foreign Trade Co. 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 Huang Mei County Minda Foreign Trade Co. come from?

All FDA import refusal data for Huang Mei County Minda Foreign Trade Co. 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.