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Procesadora de Dulces Tipicos, S.A. de C.V.

🚨 Critical Risk

FEI: 2000032640 • Guadalajara, Jalisco • MEXICO

FEI

FEI Number

2000032640

📍

Location

Guadalajara, Jalisco

🇲🇽

Country

MEXICO
🏢

Address

Calzada Independencia Norte 4405, Col. Huentitan El Bajo, Guadalajara, Guadalajara, Jalisco, Mexico

Critical Risk

FDA Import Risk Assessment

77.2
LowModerateHighCritical

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

Statistics

91
Total Refusals
16
Unique Violations
12/17/2025
Latest Refusal
2/15/2008
Earliest Refusal

Score Breakdown

Violation Severity
76.5×40%
Refusal Volume
72.7×30%
Recency
98.6×20%
Frequency
51.0×10%
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

24944×

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.

1127×

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).

27419×

COLOR LBLG

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

48210×

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.

20405×

SULFITELBL

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded because 1) it appears to contain sulfites but the label fails to declare the presence of sulfites, a fact material to sulfite-sensitive individuals who must avoid the ingredient due to potential health consequences from its consumption, and 2) it appears the food is fabricated from two or more ingredients and the label does not list the common or usual name of each ingredient.

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.

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.

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.

33002×

ALLERGEN

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

2761×

PRESRV LBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a chemical preservative and it fails to bear labeling stating that fact including its function.

3201×

LACKS FIRM

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)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

3211×

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.

3241×

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)).

2511×

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:

4731×

LABELING

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

2561×

INCONSPICU

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
12/17/2025
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
12/12/2025
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
12/10/2025
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
11/25/2025
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
11/25/2025
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
10/10/2025
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
5/30/2025
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
6/17/2024
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
1/25/2024
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
1/25/2024
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
1/25/2024
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
1/19/2024
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
12/9/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
11/16/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
11/16/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
11/1/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
11/1/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
10/17/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
9/25/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
9/12/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
9/12/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
8/24/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
8/21/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
8/11/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
8/9/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
8/8/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
8/4/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
8/4/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
5/25/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
4/21/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
4/21/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
2/21/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
2/9/2023
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
12/15/2022
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
11/1/2022
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
10/24/2022
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
12/1/2021
33HGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH COCONUT (WITHOUT CHOCOLATE)
482NUTRIT LBL
Division of Southwest Imports (DSWI)
8/6/2021
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
5/28/2021
33HGT99SOFT CANDY WITH COCONUT, N.E.C. (WITHOUT CHOCOLATE)
482NUTRIT LBL
Division of Southwest Imports (DSWI)
5/28/2021
33HGT99SOFT CANDY WITH COCONUT, N.E.C. (WITHOUT CHOCOLATE)
482NUTRIT LBL
Division of Southwest Imports (DSWI)
4/22/2020
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
3/24/2020
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
12/11/2019
33LGT09MARSHMALLOW CANDY, SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
12/11/2019
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Division of Southwest Imports (DSWI)
10/7/2019
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
218LIST INGRE
Division of Southwest Imports (DSWI)
8/14/2019
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
482NUTRIT LBL
Division of Southwest Imports (DSWI)
8/7/2019
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
482NUTRIT LBL
Division of Southwest Imports (DSWI)
8/2/2019
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
5/30/2019
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
5/30/2019
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
4/19/2019
33HGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH COCONUT (WITHOUT CHOCOLATE)
260FALSE
Division of Southwest Imports (DSWI)
9/19/2018
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
324NO ENGLISH
482NUTRIT LBL
Division of Southwest Imports (DSWI)
9/19/2018
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
256INCONSPICU
482NUTRIT LBL
Division of Southwest Imports (DSWI)
9/11/2018
33HGT99SOFT CANDY WITH COCONUT, N.E.C. (WITHOUT CHOCOLATE)
2040SULFITELBL
274COLOR LBLG
482NUTRIT LBL
Division of Southwest Imports (DSWI)
9/5/2018
33HGT99SOFT CANDY WITH COCONUT, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
6/29/2018
33HGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH COCONUT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
6/13/2018
33HGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH COCONUT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
6/13/2018
33HGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH COCONUT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
6/13/2018
33HGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH COCONUT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
6/13/2018
33HGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH COCONUT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
6/13/2018
33HGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH COCONUT (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
5/8/2018
33HGT99SOFT CANDY WITH COCONUT, N.E.C. (WITHOUT CHOCOLATE)
3300ALLERGEN
Division of Southwest Imports (DSWI)
5/8/2018
33HGT99SOFT CANDY WITH COCONUT, N.E.C. (WITHOUT CHOCOLATE)
3300ALLERGEN
Division of Southwest Imports (DSWI)
8/7/2017
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
2/23/2017
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
12/8/2016
03HGT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
11UNSAFE COL
274COLOR LBLG
Division of Southwest Imports (DSWI)
8/26/2016
03HFT99PLAIN COOKIES,BISCUITS AND WAFERS, N.E.C.
11UNSAFE COL
Southwest Import District Office (SWI-DO)
5/25/2016
33JGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH FRUIT (WITHOUT CHOCOLATE)
11UNSAFE COL
Division of Southwest Imports (DSWI)
4/14/2016
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
4/14/2016
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
4/14/2016
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
4/14/2016
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
3/2/2016
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
3/2/2016
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
274COLOR LBLG
Southwest Import District Office (SWI-DO)
2/29/2016
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
251POISONOUS
276PRESRV LBL
473LABELING
Southwest Import District Office (SWI-DO)
2/18/2016
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
2/18/2016
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
2/18/2016
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
11UNSAFE COL
Southwest Import District Office (SWI-DO)
12/2/2015
33EFB01CARAMEL CANDY BAR, HARD, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
274COLOR LBLG
Southwest Import District Office (SWI-DO)
7/30/2015
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
6/23/2015
09CHT99MILK AND CREAM, N.E.C.
11UNSAFE COL
260FALSE
274COLOR LBLG
320LACKS FIRM
321LACKS N/C
482NUTRIT LBL
Southwest Import District Office (SWI-DO)
4/22/2014
21UGT04GUAVA, JAM, JELLY, PRESERVES, MARMALADE, BUTTER OR CANDIED
249FILTHY
Division of Southwest Imports (DSWI)
4/18/2014
33HGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH COCONUT (WITHOUT CHOCOLATE)
238UNSAFE ADD
Southwest Import District Office (SWI-DO)
1/6/2014
33SGT99CANDY SPECIALTIES, N.E.C. (WITHOUT CHOCOLATE)
238UNSAFE ADD
Southwest Import District Office (SWI-DO)
9/4/2013
33HGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH COCONUT (WITHOUT CHOCOLATE)
2040SULFITELBL
Southwest Import District Office (SWI-DO)
11/15/2012
33SGY06LOLLIPOP (WITHOUT CHOCOLATE)
249FILTHY
Division of Southwest Imports (DSWI)
10/29/2012
33HGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH COCONUT (WITHOUT CHOCOLATE)
2040SULFITELBL
Southwest Import District Office (SWI-DO)
9/19/2012
33HGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH COCONUT (WITHOUT CHOCOLATE)
2040SULFITELBL
Southwest Import District Office (SWI-DO)
7/26/2010
33SGT06LOLLIPOP (WITHOUT CHOCOLATE)
218LIST INGRE
249FILTHY
Southwest Import District Office (SWI-DO)
4/16/2010
33LMT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITHOUT NUTS AND FRUIT (WITHOUT CHOCOLATE)
249FILTHY
Southwest Import District Office (SWI-DO)
2/15/2008
33HGT05CANDY BAR OR PIECES (NOT CARAMEL OR FONDANT), SOFT, WITH COCONUT (WITHOUT CHOCOLATE)
2040SULFITELBL
482NUTRIT LBL
Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is Procesadora de Dulces Tipicos, S.A. de C.V.'s FDA import refusal history?

Procesadora de Dulces Tipicos, S.A. de C.V. (FEI: 2000032640) has 91 FDA import refusal record(s) in our database, spanning from 2/15/2008 to 12/17/2025.

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. Procesadora de Dulces Tipicos, S.A. de C.V.'s FEI number is 2000032640.

What types of violations has Procesadora de Dulces Tipicos, S.A. de C.V. received?

Procesadora de Dulces Tipicos, S.A. de C.V. has been cited for 16 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 Procesadora de Dulces Tipicos, S.A. de C.V. come from?

All FDA import refusal data for Procesadora de Dulces Tipicos, 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.