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Ehealthcare

⚠️ Moderate Risk

FEI: 3011878287 • Burnaby, British Columbia • CANADA

FEI

FEI Number

3011878287

📍

Location

Burnaby, British Columbia

🇨🇦

Country

CANADA
🏢

Address

6368 Caulwynd Pl, , Burnaby, British Columbia, Canada

Moderate Risk

FDA Import Risk Assessment

25.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
4
Unique Violations
10/26/2016
Latest Refusal
10/26/2016
Earliest Refusal

Score Breakdown

Violation Severity
52.5×40%
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

23001×

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.

38641×

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.

4821×

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.

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
10/26/2016
54FBR99HERBALS & BOTANICALS (NOT TEAS), N.E.C.
2300DIETARYLBL
3864NCONTACT
482NUTRIT LBL
75UNAPPROVED
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Ehealthcare's FDA import refusal history?

Ehealthcare (FEI: 3011878287) has 1 FDA import refusal record(s) in our database, spanning from 10/26/2016 to 10/26/2016.

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. Ehealthcare's FEI number is 3011878287.

What types of violations has Ehealthcare received?

Ehealthcare has been cited for 4 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 Ehealthcare come from?

All FDA import refusal data for Ehealthcare 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.