HARMONIC ARTS
⚠️ Moderate Risk
FEI: 3014796569 • Cumberland, British Columbia • CANADA
FEI Number
3014796569
Location
Cumberland, British Columbia
Country
CANADAAddress
2660 Dunsmuir Avenue, , Cumberland, British Columbia, Canada
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
Statistics
Score Breakdown
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
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.
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.
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.
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).
LACKS FIRM
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/22/2024 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 8/22/2024 | 25SGH99FUNGI PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 8/22/2024 | 25SGH99FUNGI PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 8/22/2024 | 25SGH99FUNGI PRODUCTS NOT MENTIONED ELSEWHERE, N.E.C. | Division of Northern Border Imports (DNBI) | |
| 8/22/2024 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 8/22/2024 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 8/22/2024 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 8/22/2024 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is HARMONIC ARTS's FDA import refusal history?
HARMONIC ARTS (FEI: 3014796569) has 8 FDA import refusal record(s) in our database, spanning from 8/22/2024 to 8/22/2024.
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. HARMONIC ARTS's FEI number is 3014796569.
What types of violations has HARMONIC ARTS received?
HARMONIC ARTS has been cited for 5 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 HARMONIC ARTS come from?
All FDA import refusal data for HARMONIC ARTS 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.