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SANFER SALUD ANIMAL SA DE CV

⚠️ Moderate Risk

FEI: 3017933131 • Alvaro Obregon, Mexico • MEXICO

FEI

FEI Number

3017933131

📍

Location

Alvaro Obregon, Mexico

🇲🇽

Country

MEXICO
🏢

Address

Boulevard Adolfo Lopez Mateos #314, Planta Baja, Colonia Tlacopac, Alvaro Obregon, Mexico, Mexico

Moderate Risk

FDA Import Risk Assessment

34.5
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
12/7/2022
Latest Refusal
12/7/2022
Earliest Refusal

Score Breakdown

Violation Severity
63.3×40%
Refusal Volume
11.2×30%
Recency
24.1×20%
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

1181×

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).

32801×

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.

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
12/7/2022
60LDA01ACETAMINOPHEN (ANALGESIC)
118NOT LISTED
3280FRNMFGREG
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SANFER SALUD ANIMAL SA DE CV's FDA import refusal history?

SANFER SALUD ANIMAL SA DE CV (FEI: 3017933131) has 1 FDA import refusal record(s) in our database, spanning from 12/7/2022 to 12/7/2022.

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. SANFER SALUD ANIMAL SA DE CV's FEI number is 3017933131.

What types of violations has SANFER SALUD ANIMAL SA DE CV received?

SANFER SALUD ANIMAL SA DE CV has been cited for 3 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 SANFER SALUD ANIMAL SA DE CV come from?

All FDA import refusal data for SANFER SALUD ANIMAL SA DE CV 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.