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Productos Karla, S.A. de C.V.

🚨 Critical Risk

FEI: 1000475421 • Col. Tabasco, Zacatecas • MEXICO

FEI

FEI Number

1000475421

📍

Location

Col. Tabasco, Zacatecas

🇲🇽

Country

MEXICO
🏢

Address

Carretera Guadalajara - Saltillo Km 187, Tabasco, Col. Tabasco, Zacatecas, Mexico

Critical Risk

FDA Import Risk Assessment

78.2
LowModerateHighCritical

This firm has an extensive history of FDA import refusals with severe violations.

Statistics

123
Total Refusals
13
Unique Violations
5/7/2024
Latest Refusal
10/6/2003
Earliest Refusal

Score Breakdown

Violation Severity
89.1×40%
Refusal Volume
77.5×30%
Recency
66.4×20%
Frequency
59.7×10%
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

24995×

FILTHY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.

25111×

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:

34009×

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.

118×

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).

2748×

COLOR LBLG

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

4824×

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.

3212×

LACKS N/C

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)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

3242×

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)).

2602×

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.

1712×

CONTAINER

The container appears to be composed, in whole or in part, of a poisonous or deleterious substance which may render the contents injurious to health.

2182×

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.

3281×

USUAL NAME

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)(1) of the FD&C Act in that the label fails to bear the common or usual name of the food, if any there be.

4731×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

Refusal History

DateProductViolationsDivision
5/7/2024
33CHT99HARD CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE)
321LACKS N/C
324NO ENGLISH
482NUTRIT LBL
Division of Southwest Imports (DSWI)
3/12/2024
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
10/23/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
274COLOR LBLG
Division of Southwest Imports (DSWI)
10/23/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
274COLOR LBLG
Division of Southwest Imports (DSWI)
8/29/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Division of Southwest Imports (DSWI)
8/24/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
8/11/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
7/18/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
7/18/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
4/14/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
324NO ENGLISH
Division of Southwest Imports (DSWI)
4/17/2020
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
12/13/2017
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
11/20/2017
33CHT99HARD CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
260FALSE
Division of Southwest Imports (DSWI)
7/6/2017
33CHT99HARD CANDY WITH FRUIT, N.E.C. (WITHOUT CHOCOLATE)
260FALSE
Division of Southwest Imports (DSWI)
11/15/2016
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/30/2016
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
9/9/2016
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
9/7/2016
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
8/31/2016
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
8/24/2016
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
8/15/2016
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
8/9/2016
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
8/5/2016
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
5/25/2016
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
5/25/2016
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
4/11/2016
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
473LABELING
482NUTRIT LBL
Division of Southwest Imports (DSWI)
4/6/2016
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
3/16/2016
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
3/15/2016
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
12/30/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/7/2015
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/28/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/21/2015
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
7/20/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
7/10/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
7/10/2015
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/9/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
4/29/2015
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/9/2014
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
5/2/2014
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
251POISONOUS
Southwest Import District Office (SWI-DO)
4/22/2014
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
3/14/2014
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
1/3/2014
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
12/24/2013
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
3400PB-FOOD
Southwest Import District Office (SWI-DO)
12/6/2013
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
11/27/2013
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
251POISONOUS
Southwest Import District Office (SWI-DO)
11/27/2013
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
251POISONOUS
Southwest Import District Office (SWI-DO)
7/16/2013
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/25/2013
33SHT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
251POISONOUS
Southwest Import District Office (SWI-DO)
6/25/2013
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
5/25/2012
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
5/25/2012
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
4/4/2012
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
4/4/2012
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
2/24/2012
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
1/19/2012
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
171CONTAINER
251POISONOUS
3400PB-FOOD
Chicago District Office (CHI-DO)
1/19/2012
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
171CONTAINER
251POISONOUS
3400PB-FOOD
Chicago District Office (CHI-DO)
12/2/2011
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/3/2011
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
321LACKS N/C
328USUAL NAME
3400PB-FOOD
482NUTRIT LBL
Southwest Import District Office (SWI-DO)
4/20/2011
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
4/20/2011
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
1/7/2011
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
3400PB-FOOD
Southwest Import District Office (SWI-DO)
1/7/2011
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
3400PB-FOOD
Southwest Import District Office (SWI-DO)
1/7/2011
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
1/7/2011
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
1/7/2011
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
10/27/2010
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/29/2010
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
4/16/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
4/16/2010
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
3400PB-FOOD
Southwest Import District Office (SWI-DO)
4/16/2010
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/11/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/11/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/2/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
8/26/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
8/26/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
8/17/2009
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
218LIST INGRE
249FILTHY
Southwest Import District Office (SWI-DO)
8/10/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
8/10/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
7/29/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
7/23/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
7/23/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
7/20/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/25/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/25/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/12/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/12/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
5/4/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
5/4/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
5/4/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
4/15/2009
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/17/2008
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
9/8/2008
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
7/25/2008
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
7/25/2008
33LGT07JELLIED CANDY, SOFT (JELLY BEANS, GUM DROPS, ETC.), WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
7/21/2008
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
7/15/2008
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
7/1/2008
21TGT14TAMARIND, DRIED OR PASTE
3400PB-FOOD
Southwest Import District Office (SWI-DO)
6/26/2008
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/20/2008
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Productos Karla, S.A. de C.V.'s FDA import refusal history?

Productos Karla, S.A. de C.V. (FEI: 1000475421) has 123 FDA import refusal record(s) in our database, spanning from 10/6/2003 to 5/7/2024.

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. Productos Karla, S.A. de C.V.'s FEI number is 1000475421.

What types of violations has Productos Karla, S.A. de C.V. received?

Productos Karla, S.A. de C.V. has been cited for 13 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 Productos Karla, S.A. de C.V. come from?

All FDA import refusal data for Productos Karla, 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.