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Salud y Bienestar Animal, S.A. de C.V.

⚠️ Moderate Risk

FEI: 3004167614 • Ciudad De Mexico, Ciudad de Mexico • MEXICO

FEI

FEI Number

3004167614

📍

Location

Ciudad De Mexico, Ciudad de Mexico

🇲🇽

Country

MEXICO
🏢

Address

Calle Anaxagoras 1408, Col. Santa Cruz Atoyac, Benito Juarez, Ciudad De Mexico, Ciudad de Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

26.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
10/28/2011
Latest Refusal
10/28/2011
Earliest Refusal

Score Breakdown

Violation Severity
55.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
Frequency
10.0×10%
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

4721×

NO ENGLISH

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

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.

Refusal History

DateProductViolationsDivision
10/28/2011
64SRN19PENTOBARBITAL SODIUM (HYPNOTIC)
472NO ENGLISH
72NEW VET DR
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Salud y Bienestar Animal, S.A. de C.V.'s FDA import refusal history?

Salud y Bienestar Animal, S.A. de C.V. (FEI: 3004167614) has 1 FDA import refusal record(s) in our database, spanning from 10/28/2011 to 10/28/2011.

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. Salud y Bienestar Animal, S.A. de C.V.'s FEI number is 3004167614.

What types of violations has Salud y Bienestar Animal, S.A. de C.V. received?

Salud y Bienestar Animal, 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 Salud y Bienestar Animal, S.A. de C.V. come from?

All FDA import refusal data for Salud y Bienestar Animal, 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.