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World Health Products, LLC.

⚠️ Moderate Risk

FEI: 3003978604 • Draper, UT • UNITED STATES

FEI

FEI Number

3003978604

📍

Location

Draper, UT

🇺🇸
🏢

Address

12685 S 125 E, , Draper, UT, United States

Moderate Risk

FDA Import Risk Assessment

37.4
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
1/30/2006
Latest Refusal
8/27/2004
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
14.0×10%
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).

1181×

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
1/30/2006
66VAM99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
8/27/2004
63JCM99CHELATING AGENT N.E.C.
118NOT LISTED
75UNAPPROVED
New York District Office (NYK-DO)

Frequently Asked Questions

What is World Health Products, LLC.'s FDA import refusal history?

World Health Products, LLC. (FEI: 3003978604) has 2 FDA import refusal record(s) in our database, spanning from 8/27/2004 to 1/30/2006.

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. World Health Products, LLC.'s FEI number is 3003978604.

What types of violations has World Health Products, LLC. received?

World Health Products, LLC. 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 World Health Products, LLC. come from?

All FDA import refusal data for World Health Products, LLC. 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.