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Biozeal, LLC dba ChildLife Essentials

⚠️ Moderate Risk

FEI: 3005364335 • El Segundo, CA • UNITED STATES

FEI

FEI Number

3005364335

📍

Location

El Segundo, CA

🇺🇸
🏢

Address

645 S Allied Way, , El Segundo, CA, United States

Moderate Risk

FDA Import Risk Assessment

42.9
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
8/22/2020
Latest Refusal
3/13/2007
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
2.2×10%
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

753×

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
8/22/2020
54ABL14VIT D
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/13/2007
66VBR99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)
3/13/2007
66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Biozeal, LLC dba ChildLife Essentials's FDA import refusal history?

Biozeal, LLC dba ChildLife Essentials (FEI: 3005364335) has 3 FDA import refusal record(s) in our database, spanning from 3/13/2007 to 8/22/2020.

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. Biozeal, LLC dba ChildLife Essentials's FEI number is 3005364335.

What types of violations has Biozeal, LLC dba ChildLife Essentials received?

Biozeal, LLC dba ChildLife Essentials 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 Biozeal, LLC dba ChildLife Essentials come from?

All FDA import refusal data for Biozeal, LLC dba ChildLife Essentials 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.