Soylutions Inc.
⚠️ Moderate Risk
FEI: 3004681861 • Quebec, Quebec • CANADA
FEI Number
3004681861
Location
Quebec, Quebec
Country
CANADAAddress
1629 Des Affaires Ave, , Quebec, Quebec, 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
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.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
FALSE
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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/14/2015 | 29CDE99NONALCOHOLIC BEVERAGES, N.E.C. | 251POISONOUS | New York District Office (NYK-DO) |
| 1/27/2015 | 14BDF04IMITATION MILK, CHEESE TYPE PRODUCT (SOY CHEESE, ETC.) | New York District Office (NYK-DO) | |
| 12/19/2014 | 29CDE99NONALCOHOLIC BEVERAGES, N.E.C. | 251POISONOUS | New York District Office (NYK-DO) |
| 9/24/2014 | 14BDF01IMITATION MILK, FLUID MILK TYPE PRODUCT | 482NUTRIT LBL | Division of Northern Border Imports (DNBI) |
| 12/12/2012 | 38MEE04VEGETABLE BEEF BROTH (MEAT AND/OR VEGETABLE STOCK) | New York District Office (NYK-DO) | |
| 12/12/2012 | 38MEE04VEGETABLE BEEF BROTH (MEAT AND/OR VEGETABLE STOCK) | New York District Office (NYK-DO) | |
| 1/13/2012 | 14BFF01IMITATION MILK, FLUID MILK TYPE PRODUCT | 488HEALTH C | Detroit District Office (DET-DO) |
| 1/13/2012 | 14BFF01IMITATION MILK, FLUID MILK TYPE PRODUCT | 488HEALTH C | Detroit District Office (DET-DO) |
| 12/13/2011 | 14BFF01IMITATION MILK, FLUID MILK TYPE PRODUCT | 488HEALTH C | New England District Office (NWE-DO) |
| 8/2/2011 | 14BFF99IMITATION MILK OR MILK TYPE PRODUCT, N.E.C. | 488HEALTH C | Detroit District Office (DET-DO) |
| 7/7/2010 | 14BFF01IMITATION MILK, FLUID MILK TYPE PRODUCT | New England District Office (NWE-DO) | |
| 6/22/2010 | 14BFF01IMITATION MILK, FLUID MILK TYPE PRODUCT | 488HEALTH C | Detroit District Office (DET-DO) |
| 6/22/2010 | 14BFF01IMITATION MILK, FLUID MILK TYPE PRODUCT | Detroit District Office (DET-DO) | |
| 3/24/2009 | 30GDF99BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C. | New York District Office (NYK-DO) | |
| 9/22/2006 | 14BDF99IMITATION MILK OR MILK TYPE PRODUCT, N.E.C. | 218LIST INGRE | New York District Office (NYK-DO) |
Frequently Asked Questions
What is Soylutions Inc.'s FDA import refusal history?
Soylutions Inc. (FEI: 3004681861) has 15 FDA import refusal record(s) in our database, spanning from 9/22/2006 to 7/14/2015.
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. Soylutions Inc.'s FEI number is 3004681861.
What types of violations has Soylutions Inc. received?
Soylutions 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 Soylutions Inc. come from?
All FDA import refusal data for Soylutions 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.