The Winning Combination Inc.
⚠️ Moderate Risk
FEI: 3009921570 • Winnipeg, Manitoba • CANADA
FEI Number
3009921570
Location
Winnipeg, Manitoba
Country
CANADAAddress
1099 Wilkes Ave Unit 6, , 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
TRANSFAT
The product is misbranded under Section 403(q) because the nutrition label does not provide all of the information required by 21 CFR 101.9(c); specifically, the label does not bear the amount of trans fat [21 CFR 101.9(c)(2)(ii)].
UNSAFE ADD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain an unsafe food additive within the meaning of section 409.
LACKS N/C
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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.
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).
EPHEDALK
The product is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a dietary supplement or a dietary ingredient that appears to contain ephedrine alkaloids, which presents an unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling, or if no conditions of use are suggested in the labeling, under ordinary conditions of use.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
SBGINSENG
The article is subject to refusal of admission in that it appears to be Misbranded because it or its ingredients purport to be or are represented as Ginseng, but are not an herb or herbal ingredient derived from a plant classified within the genus Panax.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/13/2019 | 54EBY09EPHEDRA (HERBAL & BOTANICAL TEAS) | 3120EPHEDALK | Division of Southeast Imports (DSEI) |
| 7/13/2018 | 60CJY22EPHEDRINE HCL (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/27/2018 | 60CCA22EPHEDRINE HCL (ADRENERGIC) | 75UNAPPROVED | Division of Northern Border Imports (DNBI) |
| 1/5/2016 | 54YCH99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 488HEALTH C | Detroit District Office (DET-DO) |
| 2/3/2014 | 54FCA12GINSENG (HERBAL & BOTANICALS, NOT TEAS) | 3140SBGINSENG | Seattle District Office (SEA-DO) |
| 2/10/2010 | 09DHY34WHEY PROTEIN CONCENTRATE | New York District Office (NYK-DO) | |
| 2/10/2010 | 09DHY34WHEY PROTEIN CONCENTRATE | New York District Office (NYK-DO) | |
| 2/10/2010 | 09DHY34WHEY PROTEIN CONCENTRATE | New York District Office (NYK-DO) | |
| 2/5/2010 | 54YBY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 473LABELING | New York District Office (NYK-DO) |
| 2/5/2010 | 09DHY34WHEY PROTEIN CONCENTRATE | New York District Office (NYK-DO) | |
| 2/5/2010 | 09DHY34WHEY PROTEIN CONCENTRATE | New York District Office (NYK-DO) | |
| 2/5/2010 | 09DHY34WHEY PROTEIN CONCENTRATE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is The Winning Combination Inc.'s FDA import refusal history?
The Winning Combination Inc. (FEI: 3009921570) has 12 FDA import refusal record(s) in our database, spanning from 2/5/2010 to 12/13/2019.
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. The Winning Combination Inc.'s FEI number is 3009921570.
What types of violations has The Winning Combination Inc. received?
The Winning Combination Inc. has been cited for 8 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 The Winning Combination Inc. come from?
All FDA import refusal data for The Winning Combination 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.