Pisa Agropecuaria, S.A. de C.V.

⚠️ High Risk

FEI: 1000461670 • Guadalajara, Jalisco • MEXICO

FEI

FEI Number

1000461670

📍

Location

Guadalajara, Jalisco

🇲🇽

Country

MEXICO

🏢

Address

Avenida Espana 1840, Col. Moderna, Guadalajara, Guadalajara, Jalisco, Mexico

High Risk

FDA Import Risk Assessment

55.5

LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

Total Refusals

Unique Violations

9/23/2024

Latest Refusal

3/14/2005

Earliest Refusal

Score Breakdown

Violation Severity

58.3×40%

Refusal Volume

53.6×30%

Recency

73.7×20%

Frequency

13.8×10%

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

Violation Summary

1113×

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).

27413×

COLOR LBLG

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

4736×

LABELING

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

2186×

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.

755×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

4825×

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.

723×

NEW VET DR

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.

32802×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

1182×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

4722×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

Refusal History

Date	Product	Violations	Division
9/23/2024	61TRP99ANTI-EMETIC/NAUSEANT N.E.C.	118NOT LISTED 3280FRNMFGREG 472NO ENGLISH 72NEW VET DR	Division of Southeast Imports (DSEI)
9/23/2024	65CRP99NUTRIENT/TONIC N.E.C.	118NOT LISTED 3280FRNMFGREG 472NO ENGLISH 72NEW VET DR	Division of Southeast Imports (DSEI)
7/22/2024	56CCY99CEPHALOSPORIN N.E.C.	75UNAPPROVED	Division of Southeast Imports (DSEI)
4/14/2023	41GHT03ORAL REHYDRATION PRODUCTS	11UNSAFE COL 274COLOR LBLG	Division of Southwest Imports (DSWI)
4/14/2023	41GHT03ORAL REHYDRATION PRODUCTS	11UNSAFE COL 274COLOR LBLG	Division of Southwest Imports (DSWI)
4/14/2023	41GHT03ORAL REHYDRATION PRODUCTS	11UNSAFE COL 274COLOR LBLG	Division of Southwest Imports (DSWI)
4/12/2023	41GHT03ORAL REHYDRATION PRODUCTS	11UNSAFE COL 274COLOR LBLG	Division of Southwest Imports (DSWI)
4/12/2023	41GHT03ORAL REHYDRATION PRODUCTS	11UNSAFE COL 274COLOR LBLG	Division of Southwest Imports (DSWI)
4/12/2023	41GHT03ORAL REHYDRATION PRODUCTS	11UNSAFE COL 274COLOR LBLG	Division of Southwest Imports (DSWI)
4/12/2023	41GHT03ORAL REHYDRATION PRODUCTS	11UNSAFE COL 274COLOR LBLG	Division of Southwest Imports (DSWI)
4/12/2023	41GHT03ORAL REHYDRATION PRODUCTS	11UNSAFE COL 274COLOR LBLG	Division of Southwest Imports (DSWI)
4/12/2023	41GHT03ORAL REHYDRATION PRODUCTS	11UNSAFE COL 274COLOR LBLG	Division of Southwest Imports (DSWI)
4/12/2023	41GHT03ORAL REHYDRATION PRODUCTS	11UNSAFE COL 274COLOR LBLG	Division of Southwest Imports (DSWI)
4/12/2023	41GHT03ORAL REHYDRATION PRODUCTS	11UNSAFE COL 274COLOR LBLG	Division of Southwest Imports (DSWI)
4/12/2023	41GHT03ORAL REHYDRATION PRODUCTS	11UNSAFE COL 274COLOR LBLG	Division of Southwest Imports (DSWI)
4/12/2023	41GHT03ORAL REHYDRATION PRODUCTS	11UNSAFE COL 274COLOR LBLG	Division of Southwest Imports (DSWI)
9/28/2022	54YNK99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.	75UNAPPROVED	Division of Southeast Imports (DSEI)
9/20/2022	62GRK37FLUNIXIN MEGLUMINE (ANTI-INFLAMMATORY)	75UNAPPROVED	Division of Southeast Imports (DSEI)
7/22/2022	29CHT99NONALCOHOLIC BEVERAGES, N.E.C.	75UNAPPROVED	Division of Southwest Imports (DSWI)
5/11/2020	61CPY08EPOETIN ALFA	72NEW VET DR	Division of Southeast Imports (DSEI)
10/8/2009	41GGT03ORAL REHYDRATION PRODUCTS	218LIST INGRE 473LABELING 482NUTRIT LBL	Southwest Import District Office (SWI-DO)
10/8/2009	41GGT03ORAL REHYDRATION PRODUCTS	218LIST INGRE 473LABELING 482NUTRIT LBL	Southwest Import District Office (SWI-DO)
10/8/2009	41GGT03ORAL REHYDRATION PRODUCTS	218LIST INGRE 473LABELING 482NUTRIT LBL	Southwest Import District Office (SWI-DO)
10/8/2009	41GGT03ORAL REHYDRATION PRODUCTS	218LIST INGRE 473LABELING 482NUTRIT LBL	Southwest Import District Office (SWI-DO)
10/8/2009	41GGT03ORAL REHYDRATION PRODUCTS	218LIST INGRE 473LABELING 482NUTRIT LBL	Southwest Import District Office (SWI-DO)
10/8/2009	41GGT03ORAL REHYDRATION PRODUCTS	218LIST INGRE 473LABELING	Southwest Import District Office (SWI-DO)
3/14/2005	61PCP99ANTI-DIABETIC N.E.C.	75UNAPPROVED	New Orleans District Office (NOL-DO)

Frequently Asked Questions

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

Pisa Agropecuaria, S.A. de C.V. (FEI: 1000461670) has 27 FDA import refusal record(s) in our database, spanning from 3/14/2005 to 9/23/2024.

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. Pisa Agropecuaria, S.A. de C.V.'s FEI number is 1000461670.

What types of violations has Pisa Agropecuaria, S.A. de C.V. received?

Pisa Agropecuaria, S.A. de C.V. has been cited for 10 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 Pisa Agropecuaria, S.A. de C.V. come from?

All FDA import refusal data for Pisa Agropecuaria, 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.