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Dicon Pacific

⚠️ Moderate Risk

FEI: 3010164594 • Dong Guan, Guangdong • CHINA

FEI

FEI Number

3010164594

📍

Location

Dong Guan, Guangdong

🇨🇳

Country

CHINA
🏢

Address

Shuifengnian Industrial Park, Shatianzhen, Dong Guan, Guangdong, China

Moderate Risk

FDA Import Risk Assessment

43.3
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
12/15/2008
Latest Refusal
12/15/2008
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
12/15/2008
60LAY99ANALGESIC, N.E.C.
75UNAPPROVED
Seattle District Office (SEA-DO)
12/15/2008
60LAY99ANALGESIC, N.E.C.
75UNAPPROVED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Dicon Pacific's FDA import refusal history?

Dicon Pacific (FEI: 3010164594) has 2 FDA import refusal record(s) in our database, spanning from 12/15/2008 to 12/15/2008.

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. Dicon Pacific's FEI number is 3010164594.

What types of violations has Dicon Pacific received?

Dicon Pacific 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 Dicon Pacific come from?

All FDA import refusal data for Dicon Pacific 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.