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Agrovet S.A. De C.V.

⚠️ Moderate Risk

FEI: 3011863317 • Guadalajara, Jalisco • MEXICO

FEI

FEI Number

3011863317

📍

Location

Guadalajara, Jalisco

🇲🇽

Country

MEXICO
🏢

Address

Ala, Privada Juan de La Barrera 3485, Guadalajara, Jalisco, Mexico

Moderate Risk

FDA Import Risk Assessment

43.2
LowModerateHighCritical

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

Statistics

2
Total Refusals
2
Unique Violations
7/20/2022
Latest Refusal
5/11/2020
Earliest Refusal

Score Breakdown

Violation Severity
85.0×40%
Refusal Volume
17.7×30%
Recency
15.1×20%
Frequency
9.1×10%
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

721×

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.

751×

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).

Refusal History

DateProductViolationsDivision
7/20/2022
62GCY99ANTI-INFLAMMATORY N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)
5/11/2020
54AMY10MECOBALAMIN (VITAMIN)
72NEW VET DR
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Agrovet S.A. De C.V.'s FDA import refusal history?

Agrovet S.A. De C.V. (FEI: 3011863317) has 2 FDA import refusal record(s) in our database, spanning from 5/11/2020 to 7/20/2022.

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. Agrovet S.A. De C.V.'s FEI number is 3011863317.

What types of violations has Agrovet S.A. De C.V. received?

Agrovet S.A. De C.V. has been cited for 2 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 Agrovet S.A. De C.V. come from?

All FDA import refusal data for Agrovet 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.