Monfitello Inc.
⚠️ Moderate Risk
FEI: 3007992770 • Lachine, Quebec • CANADA
FEI Number
3007992770
Location
Lachine, Quebec
Country
CANADAAddress
2700 Jean-Baptiste-Deschamps Blvd, , Lachine, 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
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.
NCONTACTS
The product is a dietary supplement that is marketed in the United States and appears to not have a domestic address or domestic phone number through which the responsible person may receive a report of a serious adverse event.
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.
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.
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.
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.
PB-FOOD
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a poisonous or deleterious substance, lead, which may render it injurious to health.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/30/2020 | 28LEO99MIXED SPICES AND SEASONINGS, LIQUID, WITH SALT, N.E.C. | 3400PB-FOOD | Division of Northern Border Imports (DNBI) |
| 3/19/2014 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/13/2013 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New Orleans District Office (NOL-DO) | |
| 12/13/2013 | 54FCL99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | New Orleans District Office (NOL-DO) | |
| 11/22/2013 | 54YYY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Monfitello Inc.'s FDA import refusal history?
Monfitello Inc. (FEI: 3007992770) has 5 FDA import refusal record(s) in our database, spanning from 11/22/2013 to 4/30/2020.
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. Monfitello Inc.'s FEI number is 3007992770.
What types of violations has Monfitello Inc. received?
Monfitello 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 Monfitello Inc. come from?
All FDA import refusal data for Monfitello 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.