Faunus Herbs Inc.
⚠️ Moderate Risk
FEI: 3010126941 • Sunderland, Ontario • CANADA
FEI Number
3010126941
Location
Sunderland, Ontario
Country
CANADAAddress
S135 Brock Concession Rd #10, , Sunderland, Ontario, 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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
DIETARYING
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)(A) of the FD&C Act in that the dietary supplement label or labeling fails to list the name of each dietary ingredient of the supplement and the quantity of each such dietary ingredient or , with respect to a proprietary blend of such dietary ingredients, the total quantity of all dietary ingredients in the blend.
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.
LIST INGRE
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(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.
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.
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/8/2022 | 54FAL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Northern Border Imports (DNBI) | |
| 1/7/2016 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 1/7/2016 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New York District Office (NYK-DO) | |
| 11/7/2011 | 54YCE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New York District Office (NYK-DO) | |
| 12/4/2002 | 54ABH99VITAMIN, N.E.C. | Detroit District Office (DET-DO) |
Frequently Asked Questions
What is Faunus Herbs Inc.'s FDA import refusal history?
Faunus Herbs Inc. (FEI: 3010126941) has 5 FDA import refusal record(s) in our database, spanning from 12/4/2002 to 2/8/2022.
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. Faunus Herbs Inc.'s FEI number is 3010126941.
What types of violations has Faunus Herbs Inc. received?
Faunus Herbs Inc. has been cited for 9 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 Faunus Herbs Inc. come from?
All FDA import refusal data for Faunus Herbs 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.