MONTES Y CIA., S.A. DE C.V.
⚠️ Moderate Risk
FEI: 3004255853 • Poncitlan, Jalisco • MEXICO
FEI Number
3004255853
Location
Poncitlan, Jalisco
Country
MEXICOAddress
Calle Miguel Montes C. # 32, Col. Centro, Poncitlan, Jalisco, Mexico
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
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
COLOR LBLG
The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.
NO ENGLISH
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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).
ALLERGEN
the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).
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:
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.
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.
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.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/30/2017 | 33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | Division of Southwest Imports (DSWI) | |
| 5/24/2017 | 33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | Division of Southwest Imports (DSWI) | |
| 5/16/2017 | 33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) | Division of Southwest Imports (DSWI) | |
| 5/16/2017 | 33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | 11UNSAFE COL | Division of Southwest Imports (DSWI) |
| 5/16/2017 | 33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | 11UNSAFE COL | Division of Southwest Imports (DSWI) |
| 5/11/2017 | 33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | Division of Southwest Imports (DSWI) | |
| 5/11/2017 | 33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | Division of Southwest Imports (DSWI) | |
| 5/11/2017 | 33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | Division of Southwest Imports (DSWI) | |
| 1/6/2017 | 33EGT02CARAMEL CANDY PIECES, HARD, WITHOUT NUTS OR FRUIT (WITHOUT CHOCOLATE) | Division of Southwest Imports (DSWI) | |
| 1/6/2017 | 33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | Division of Southwest Imports (DSWI) | |
| 1/6/2017 | 33GGT12MIXED/ASSORTED SOFT CANDY WITH NUTS, NUT PRODUCTS, OR SEEDS W/O COCONUT OR CHOCOLATE | Division of Southwest Imports (DSWI) | |
| 12/15/2016 | 33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) | Southwest Import District Office (SWI-DO) | |
| 12/13/2016 | 33EHT01CARAMEL CANDY BAR, HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Southwest Import District Office (SWI-DO) | |
| 4/7/2016 | 33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) | Division of Southwest Imports (DSWI) | |
| 3/31/2016 | 33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE) | Division of Southwest Imports (DSWI) | |
| 9/11/2009 | 33LGT99SOFT CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE) | 324NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 5/22/2009 | 34FGT02CHOCOLATE CANDY PIECES, WITHOUT NUTS AND FRUIT | 3400PB-FOOD | Southwest Import District Office (SWI-DO) |
| 3/4/2009 | 34FGT99CHOCOLATE AND CHOCOLATE COVERED CANDY, WITHOUT NUTS AND FRUIT, N.E.C. | 3400PB-FOOD | Southwest Import District Office (SWI-DO) |
| 3/4/2009 | 34FGT99CHOCOLATE AND CHOCOLATE COVERED CANDY, WITHOUT NUTS AND FRUIT, N.E.C. | 3400PB-FOOD | Southwest Import District Office (SWI-DO) |
| 1/17/2006 | 33LFN02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | 324NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 1/17/2006 | 33EGT02CARAMEL CANDY PIECES, HARD, WITHOUT NUTS OR FRUIT (WITHOUT CHOCOLATE) | 324NO ENGLISH | Southwest Import District Office (SWI-DO) |
| 12/8/2005 | 34FGT02CHOCOLATE CANDY PIECES, WITHOUT NUTS AND FRUIT | 251POISONOUS | Southwest Import District Office (SWI-DO) |
| 11/16/2004 | 34BGT99CHOCOLATE AND COCOA, N.E.C. | 251POISONOUS | Southwest Import District Office (SWI-DO) |
| 10/28/2004 | 34FGT99CHOCOLATE AND CHOCOLATE COVERED CANDY, WITHOUT NUTS AND FRUIT, N.E.C. | 251POISONOUS | Southwest Import District Office (SWI-DO) |
| 6/29/2003 | 33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is MONTES Y CIA., S.A. DE C.V.'s FDA import refusal history?
MONTES Y CIA., S.A. DE C.V. (FEI: 3004255853) has 25 FDA import refusal record(s) in our database, spanning from 6/29/2003 to 5/30/2017.
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. MONTES Y CIA., S.A. DE C.V.'s FEI number is 3004255853.
What types of violations has MONTES Y CIA., S.A. DE C.V. received?
MONTES Y CIA., S.A. DE C.V. 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 MONTES Y CIA., S.A. DE C.V. come from?
All FDA import refusal data for MONTES Y CIA., S.A. DE C.V. 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.