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Naturals Distributing Inc

⚠️ Moderate Risk

FEI: 3003863312 • Langley, BC • CANADA

FEI

FEI Number

3003863312

📍

Location

Langley, BC

🇨🇦

Country

CANADA
🏢

Address

107 19789 92a Ave, , Langley, BC, Canada

Moderate Risk

FDA Import Risk Assessment

28.6
LowModerateHighCritical

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

Statistics

2
Total Refusals
3
Unique Violations
2/20/2007
Latest Refusal
2/20/2007
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
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

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).

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

751×

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
2/20/2007
62WBL99ASTRINGENT/ANTI-PERSPIRANT N.E.C.
333LACKS FIRM
75UNAPPROVED
Seattle District Office (SEA-DO)
2/20/2007
57GB01ALLERGENIC EXTRACTS, NON-STANDARDIZED
118NOT LISTED
Seattle District Office (SEA-DO)

Frequently Asked Questions

What is Naturals Distributing Inc's FDA import refusal history?

Naturals Distributing Inc (FEI: 3003863312) has 2 FDA import refusal record(s) in our database, spanning from 2/20/2007 to 2/20/2007.

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. Naturals Distributing Inc's FEI number is 3003863312.

What types of violations has Naturals Distributing Inc received?

Naturals Distributing Inc has been cited for 3 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 Naturals Distributing Inc come from?

All FDA import refusal data for Naturals Distributing Inc 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.