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Productos de Leche San Pablo,S.A. de C.V.

⚠️ Moderate Risk

FEI: 3004327892 • Linares, Nuevo Leon • MEXICO

FEI

FEI Number

3004327892

📍

Location

Linares, Nuevo Leon

🇲🇽

Country

MEXICO
🏢

Address

De Noviembre #301 Nte. 20, Col. Linares Centro, Linares, Nuevo Leon, Mexico

Moderate Risk

FDA Import Risk Assessment

48.0
LowModerateHighCritical

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

Statistics

23
Total Refusals
6
Unique Violations
1/9/2014
Latest Refusal
2/15/2002
Earliest Refusal

Score Breakdown

Violation Severity
76.8×40%
Refusal Volume
51.1×30%
Recency
0.0×20%
Frequency
19.3×10%
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

25110×

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:

34008×

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.

2183×

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.

2603×

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.

2382×

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.

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)).

Refusal History

DateProductViolationsDivision
1/9/2014
09CCP26MILK AND MILK PRODUCTS, CULTURED OR ACIDIFIED
238UNSAFE ADD
251POISONOUS
Southwest Import District Office (SWI-DO)
6/19/2013
33SGF99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
218LIST INGRE
260FALSE
Southwest Import District Office (SWI-DO)
6/19/2013
33SGF99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
218LIST INGRE
260FALSE
Southwest Import District Office (SWI-DO)
5/8/2013
33GGB05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE)
260FALSE
324NO ENGLISH
Southwest Import District Office (SWI-DO)
5/8/2013
33GGB05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE)
251POISONOUS
Southwest Import District Office (SWI-DO)
5/8/2013
33GGB05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE)
251POISONOUS
Southwest Import District Office (SWI-DO)
5/8/2013
33GGB05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE)
251POISONOUS
Southwest Import District Office (SWI-DO)
5/8/2013
33GGB05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE)
251POISONOUS
Southwest Import District Office (SWI-DO)
5/8/2013
33GGB05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE)
251POISONOUS
Southwest Import District Office (SWI-DO)
5/8/2013
33GGB05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE)
251POISONOUS
Southwest Import District Office (SWI-DO)
5/8/2013
33GGB05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH NUTS OR NUT PRODUCTS (WITHOUT CHOCOLATE)
251POISONOUS
Southwest Import District Office (SWI-DO)
1/8/2013
33SGF99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
3400PB-FOOD
Southwest Import District Office (SWI-DO)
1/8/2013
33SGF99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
3400PB-FOOD
Southwest Import District Office (SWI-DO)
12/12/2012
33SHT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
3400PB-FOOD
Southwest Import District Office (SWI-DO)
10/9/2012
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
3400PB-FOOD
Southwest Import District Office (SWI-DO)
10/5/2012
33GGT99SOFT CANDY WITH NUTS OR NUT PRODUCTS, N.E.C. (WITHOUT CHOCOLATE)
238UNSAFE ADD
251POISONOUS
Southwest Import District Office (SWI-DO)
8/27/2012
33AGT05CANDY BARS OR PIECES (NOT CARAMEL OR FONDANT), HARD, WITH NUTS OR NUT PRODUCTS (NOT COCONUT)(WITHOUT
251POISONOUS
Southwest Import District Office (SWI-DO)
6/18/2012
33GFT99SOFT CANDY WITH NUTS OR NUT PRODUCTS, N.E.C. (WITHOUT CHOCOLATE)
3400PB-FOOD
Southwest Import District Office (SWI-DO)
5/14/2012
33LGT02CARAMEL CANDY PIECES, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
218LIST INGRE
Southwest Import District Office (SWI-DO)
3/9/2012
33SGF99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
3400PB-FOOD
Division of Southwest Imports (DSWI)
3/8/2012
33GGT99SOFT CANDY WITH NUTS OR NUT PRODUCTS, N.E.C. (WITHOUT CHOCOLATE)
3400PB-FOOD
Southwest Import District Office (SWI-DO)
12/7/2011
33GGT99SOFT CANDY WITH NUTS OR NUT PRODUCTS, N.E.C. (WITHOUT CHOCOLATE)
3400PB-FOOD
Southwest Import District Office (SWI-DO)
2/15/2002
33GGT14TAFFY (TOFFEE), KISSES CANDY, SOFT, WITH NUTS OR NUT PRODUCT (WITHOUT CHOCOLATE)
324NO ENGLISH
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

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

Productos de Leche San Pablo,S.A. de C.V. (FEI: 3004327892) has 23 FDA import refusal record(s) in our database, spanning from 2/15/2002 to 1/9/2014.

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 de Leche San Pablo,S.A. de C.V.'s FEI number is 3004327892.

What types of violations has Productos de Leche San Pablo,S.A. de C.V. received?

Productos de Leche San Pablo,S.A. de C.V. has been cited for 6 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 de Leche San Pablo,S.A. de C.V. come from?

All FDA import refusal data for Productos de Leche San Pablo,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.