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MONTES Y CIA., S.A. DE C.V.

⚠️ Moderate Risk

FEI: 3004255853 • Poncitlan, Jalisco • MEXICO

FEI

FEI Number

3004255853

📍

Location

Poncitlan, Jalisco

🇲🇽

Country

MEXICO
🏢

Address

Calle Miguel Montes C. # 32, Col. Centro, Poncitlan, Jalisco, Mexico

Moderate Risk

FDA Import Risk Assessment

44.4
LowModerateHighCritical

This firm has a moderate history of FDA import refusals. Some attention may be warranted.

Statistics

25
Total Refusals
9
Unique Violations
5/30/2017
Latest Refusal
6/29/2003
Earliest Refusal

Score Breakdown

Violation Severity
67.2×40%
Refusal Volume
52.4×30%
Recency
0.0×20%
Frequency
17.9×10%
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

1114×

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).

27412×

COLOR LBLG

The article appears to contain an artificial coloring and it fails to bear labeling stating that fact.

3244×

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)).

33004×

ALLERGEN

the label fails to declare all major food allergens present in the product, as required by section 403(w)(1).

2513×

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:

34003×

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.

2181×

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.

4821×

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.

2601×

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

DateProductViolationsDivision
5/30/2017
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
3300ALLERGEN
Division of Southwest Imports (DSWI)
5/24/2017
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
3300ALLERGEN
Division of Southwest Imports (DSWI)
5/16/2017
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
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)
11UNSAFE COL
274COLOR LBLG
3300ALLERGEN
Division of Southwest Imports (DSWI)
5/11/2017
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
3300ALLERGEN
Division of Southwest Imports (DSWI)
5/11/2017
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
1/6/2017
33EGT02CARAMEL CANDY PIECES, HARD, WITHOUT NUTS OR FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
1/6/2017
33EGT99HARD CANDY WITHOUT NUTS AND FRUIT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
1/6/2017
33GGT12MIXED/ASSORTED SOFT CANDY WITH NUTS, NUT PRODUCTS, OR SEEDS W/O COCONUT OR CHOCOLATE
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
12/15/2016
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
12/13/2016
33EHT01CARAMEL CANDY BAR, HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
4/7/2016
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
3/31/2016
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
260FALSE
482NUTRIT LBL
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)
218LIST INGRE
324NO ENGLISH
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.