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US Exell Corporation

⚠️ Moderate Risk

FEI: 3004305068 • Garden Grove, CA • UNITED STATES

FEI

FEI Number

3004305068

📍

Location

Garden Grove, CA

🇺🇸
🏢

Address

12601 Monarch St, , Garden Grove, CA, United States

Moderate Risk

FDA Import Risk Assessment

36.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/24/2003
Latest Refusal
12/24/2003
Earliest Refusal

Score Breakdown

Violation Severity
80.0×40%
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

271×

DRUG GMPS

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).

Refusal History

DateProductViolationsDivision
12/24/2003
54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
27DRUG GMPS
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is US Exell Corporation's FDA import refusal history?

US Exell Corporation (FEI: 3004305068) has 1 FDA import refusal record(s) in our database, spanning from 12/24/2003 to 12/24/2003.

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. US Exell Corporation's FEI number is 3004305068.

What types of violations has US Exell Corporation received?

US Exell Corporation 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 US Exell Corporation come from?

All FDA import refusal data for US Exell Corporation 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.