Winning Combination, The
⚠️ Moderate Risk
FEI: 3004487868 • Winnipeg, Manitoba • CANADA
FEI Number
3004487868
Location
Winnipeg, Manitoba
Country
CANADAAddress
551 King Edward St, , Winnipeg, Manitoba, 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
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/2/2004 | 54YEL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 333LACKS FIRM | New Orleans District Office (NOL-DO) |
| 11/2/2004 | 54YEA99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 320LACKS FIRM | New Orleans District Office (NOL-DO) |
| 11/2/2004 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 7/2/2004 | 54YBH02CARNITINE, VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 473LABELING | Minneapolis District Office (MIN-DO) |
| 7/2/2004 | 54YBH02CARNITINE, VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 473LABELING | Minneapolis District Office (MIN-DO) |
| 7/2/2004 | 54YBH02CARNITINE, VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 473LABELING | Minneapolis District Office (MIN-DO) |
| 7/2/2004 | 54YBH02CARNITINE, VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 473LABELING | Minneapolis District Office (MIN-DO) |
| 7/2/2004 | 54YBH02CARNITINE, VIT/MIN/PROTEIN/UNCONVENTIONAL DIETARY SPEC FOR HUMAN/ANIMAL, N.E.C.) | 473LABELING | Minneapolis District Office (MIN-DO) |
Frequently Asked Questions
What is Winning Combination, The's FDA import refusal history?
Winning Combination, The (FEI: 3004487868) has 8 FDA import refusal record(s) in our database, spanning from 7/2/2004 to 11/2/2004.
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. Winning Combination, The's FEI number is 3004487868.
What types of violations has Winning Combination, The received?
Winning Combination, The 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 Winning Combination, The come from?
All FDA import refusal data for Winning Combination, The 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.