Has FDA refused shipments from Montes y Cia., S.A. de C.V.?

Yes. FDA refused 14 shipment lines from Montes y Cia., S.A. de C.V. between December 13, 2016 and July 16, 2026. The most recent, on July 16, 2026, was candy specialties, n.e.c. (without chocolate), charged as FILTHY (filthy, putrid or decomposed substance).

Why did FDA refuse Montes y Cia., S.A. de C.V.'s shipments?

The most frequent charges are UNSAFE COL (color additive unsafe under section 721, 13 lines) and COLOR LBLG (artificial coloring not declared, 11 lines).

When was Montes y Cia., S.A. de C.V. last inspected by FDA?

FDA's most recent inspection of Montes y Cia., S.A. de C.V. with a final classification is dated July 23, 2018 and was classified VAI (Voluntary Action Indicated).

What is Montes y Cia., S.A. de C.V.'s FEI number?

Montes y Cia., S.A. de C.V.'s FDA Establishment Identifier (FEI) is 3004255853.

Can shipments from Montes y Cia., S.A. de C.V. still enter the U.S.?

Shipments of chocolate flavored candy (chocolate buttons & adinetas); chocolate flavored lentils from Montes y Cia., S.A. de C.V. can be detained without physical examination under Import Alert 99-42; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).

Montes y Cia., S.A. de C.V.

FDA import alert and refusal historyPoncitlan, MexicoFEI 3004255853

Recorded by FDA as MONTES Y CIA., S.A. DE C.V.

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As of October 26, 2026, Montes y Cia., S.A. de C.V. (Poncitlan, Mexico) is on the red list of FDA Import Alert 99-42 (Foods: heavy metal (toxic element) contamination) for chocolate flavored candy (chocolate buttons & adinetas); chocolate flavored lentils, published by FDA on October 28, 2022, and has 14 FDA import refusals recorded since October 2016.

Data from FDA public records, last checked October 26, 2026. Request a correction

Current status

Import alerts: IA 99-42 · red list
Last import refusal: Jul 16, 2026Candy specialties, n.e.c. (without chocolate) · FILTHY
Last warning letter: None found
Last inspection: Jul 23, 2018Classified VAI (Voluntary Action Indicated)

Every FDA record for Montes y Cia., S.A. de C.V.

16 records, newest first. Each line links to the FDA page it came from.

2026

Jul 16, 2026Import refusal
Refused, Candy specialties, n.e.c. (without chocolate)FILTHYEntry BJG-0217389-5
Source

2022

Oct 28, 2022Import alert listing
Listed on Import Alert 99-42red listChocolate Flavored Candy (Chocolate Buttons & Adinetas); Chocolate Flavored Lentils
Source

2018

Jul 23, 2018Inspection
Inspection classified VAI (Voluntary Action Indicated)Foodborne Biological Hazards
Source

2017

May 30, 2017Import refusal
Refused, Hard candy without nuts and fruit, n.e.c. (without chocolate)UNSAFE COL COLOR LBLG ALLERGENEntry 918-4866932-0
Source
May 24, 2017Import refusal
Refused, Hard candy without nuts and fruit, n.e.c. (without chocolate)UNSAFE COL COLOR LBLG ALLERGENEntry 918-4866932-0
Source
May 16, 2017Import refusal
Refused, Hard candy without nuts and fruit, n.e.c. (without chocolate)UNSAFE COLEntry 918-4869190-2
Source
May 16, 2017Import refusal
Refused, Candy specialties, n.e.c. (without chocolate)UNSAFE COL COLOR LBLGEntry 918-4867128-4
Source
May 16, 2017Import refusal
Refused, Hard candy without nuts and fruit, n.e.c. (without chocolate)UNSAFE COLEntry 918-4869190-2
Source
May 11, 2017Import refusal
Refused, 3 lines in one entry: Hard candy without nuts and fruit, n.e.c. (without chocolate)UNSAFE COLCOLOR LBLGALLERGENEntry 918-4866932-0Show 3 linesHide lines
- Refused, Hard candy without nuts and fruit, n.e.c. (without chocolate)UNSAFE COL COLOR LBLG ALLERGENEntry 918-4866932-0Source
- Refused, Hard candy without nuts and fruit, n.e.c. (without chocolate)UNSAFE COL COLOR LBLGEntry 918-4866932-0Source
- Refused, Hard candy without nuts and fruit, n.e.c. (without chocolate)UNSAFE COL COLOR LBLG ALLERGENEntry 918-4866932-0Source
Source
Jan 6, 2017Import refusal
Refused, 2 lines in one entry: Hard candy without nuts and fruit, n.e.c. (without chocolate); Mixed/assorted soft candy with nuts, nut products, or seeds w/o coconut or chocolateUNSAFE COLCOLOR LBLGEntry 918-4848353-2Show 2 linesHide lines
- Refused, Hard candy without nuts and fruit, n.e.c. (without chocolate)UNSAFE COL COLOR LBLGEntry 918-4848353-2Source
- Refused, Mixed/assorted soft candy with nuts, nut products, or seeds w/o coconut or chocolateUNSAFE COL COLOR LBLGEntry 918-4848353-2Source
Source
Jan 6, 2017Import refusal
Refused, Caramel candy pieces, hard, without nuts or fruit (without chocolate)UNSAFE COL COLOR LBLGEntry 918-4849133-7
Source

2016

Dec 15, 2016Import refusal
Refused, Candy specialties, n.e.c. (without chocolate)UNSAFE COL COLOR LBLGEntry 9L9-0121927-4
Source
Dec 13, 2016Import refusal
Refused, Caramel candy bar, hard, without nuts and fruit (without chocolate)UNSAFE COL COLOR LBLGEntry M28-0141621-7
Source

Refusal charges, in plain English

UNSAFE COL13 refused lines
Color additive unsafe under section 721
The product appeared to be, or to contain, a color additive that is unsafe within the meaning of section 721(a) of the FD&C Act, the section that governs which color additives may be used and how.
COLOR LBLG11 refused lines
Artificial coloring not declared
The product appeared to contain an artificial coloring without labeling that states that fact.
ALLERGEN4 refused lines
Major food allergen not declared
The label appeared not to declare all major food allergens present in the product, as section 403(w) of the FD&C Act requires.
FILTHY1 refused line
Filthy, putrid or decomposed substance
The product appeared to consist in whole or in part of a filthy, putrid, or decomposed substance, or to be otherwise unfit for food.

Questions about Montes y Cia., S.A. de C.V.

Is Montes y Cia., S.A. de C.V. on an FDA import alert?: Yes. As of October 26, 2026, Montes y Cia., S.A. de C.V. is on the red list of FDA Import Alert 99-42, “Foods: heavy metal (toxic element) contamination”, for chocolate flavored candy (chocolate buttons & adinetas); chocolate flavored lentils; FDA published the listing on October 28, 2022.
Has FDA refused shipments from Montes y Cia., S.A. de C.V.?: Yes. FDA refused 14 shipment lines from Montes y Cia., S.A. de C.V. between December 13, 2016 and July 16, 2026. The most recent, on July 16, 2026, was candy specialties, n.e.c. (without chocolate), charged as FILTHY (filthy, putrid or decomposed substance).
Why did FDA refuse Montes y Cia., S.A. de C.V.'s shipments?: The most frequent charges are UNSAFE COL (color additive unsafe under section 721, 13 lines) and COLOR LBLG (artificial coloring not declared, 11 lines).
When was Montes y Cia., S.A. de C.V. last inspected by FDA?: FDA's most recent inspection of Montes y Cia., S.A. de C.V. with a final classification is dated July 23, 2018 and was classified VAI (Voluntary Action Indicated).
What is Montes y Cia., S.A. de C.V.'s FEI number?: Montes y Cia., S.A. de C.V.'s FDA Establishment Identifier (FEI) is 3004255853.
Can shipments from Montes y Cia., S.A. de C.V. still enter the U.S.?: Shipments of chocolate flavored candy (chocolate buttons & adinetas); chocolate flavored lentils from Montes y Cia., S.A. de C.V. can be detained without physical examination under Import Alert 99-42; FDA releases them only if evidence shows they do not have the listed violation. Importers must consider this listing in their FSVP evaluation (21 CFR 1.505).

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