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Natural Vitamin Direct

⚠️ Moderate Risk

FEI: 3010693191 • Burnaby, BC • CANADA

FEI

FEI Number

3010693191

📍

Location

Burnaby, BC

🇨🇦

Country

CANADA
🏢

Address

2999 Underhill Ave Unit 106, , Burnaby, BC, Canada

Moderate Risk

FDA Import Risk Assessment

40.6
LowModerateHighCritical

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

Statistics

7
Total Refusals
6
Unique Violations
6/10/2016
Latest Refusal
5/25/2016
Earliest Refusal

Score Breakdown

Violation Severity
58.9×40%
Refusal Volume
33.5×30%
Recency
0.0×20%
Frequency
70.0×10%
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

4827×

NUTRIT LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling fails to bear the required nutrition information.

756×

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).

23004×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

38644×

NCONTACT

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(y) of the FD&C Act in that the dietary supplement label fails to bear a domestic address or phone number through which the responsible person (as described in section 761 of the FD&C Act) may receive a report of a serious adverse event with such dietary supplement.

33003×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

4882×

HEALTH C

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded in that the label or labeling bears an unauthorized nutrient content/health claim.

Refusal History

DateProductViolationsDivision
6/10/2016
54YBB99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
3864NCONTACT
482NUTRIT LBL
New Orleans District Office (NOL-DO)
6/8/2016
54ACE99VITAMIN, N.E.C.
482NUTRIT LBL
75UNAPPROVED
New Orleans District Office (NOL-DO)
6/6/2016
54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
482NUTRIT LBL
75UNAPPROVED
New Orleans District Office (NOL-DO)
6/6/2016
54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
482NUTRIT LBL
75UNAPPROVED
New Orleans District Office (NOL-DO)
5/25/2016
54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
3300ALLERGEN
3864NCONTACT
482NUTRIT LBL
488HEALTH C
75UNAPPROVED
New Orleans District Office (NOL-DO)
5/25/2016
54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
3300ALLERGEN
3864NCONTACT
482NUTRIT LBL
488HEALTH C
75UNAPPROVED
New Orleans District Office (NOL-DO)
5/25/2016
54YEH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
2300DIETARYLBL
3300ALLERGEN
3864NCONTACT
482NUTRIT LBL
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Natural Vitamin Direct's FDA import refusal history?

Natural Vitamin Direct (FEI: 3010693191) has 7 FDA import refusal record(s) in our database, spanning from 5/25/2016 to 6/10/2016.

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. Natural Vitamin Direct's FEI number is 3010693191.

What types of violations has Natural Vitamin Direct received?

Natural Vitamin Direct has been cited for 6 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 Natural Vitamin Direct come from?

All FDA import refusal data for Natural Vitamin Direct 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.