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LABORATORIOS SENOSIAIN SA DE CV

⚠️ High Risk

FEI: 3030153432 • Chapultepec, Tlaxcala • MEXICO

FEI

FEI Number

3030153432

📍

Location

Chapultepec, Tlaxcala

🇲🇽

Country

MEXICO
🏢

Address

Andrews Bello No 45 Pis, Nanacamilpa De Mariano Arista, Chapultepec, Tlaxcala, Mexico

High Risk

FDA Import Risk Assessment

52.1
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/17/2025
Latest Refusal
12/17/2025
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
Refusal Volume
11.2×30%
Recency
98.7×20%
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).

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
12/17/2025
60SDY26SUCRALFATE (ANTACID)
118NOT LISTED
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LABORATORIOS SENOSIAIN SA DE CV's FDA import refusal history?

LABORATORIOS SENOSIAIN SA DE CV (FEI: 3030153432) has 1 FDA import refusal record(s) in our database, spanning from 12/17/2025 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. LABORATORIOS SENOSIAIN SA DE CV's FEI number is 3030153432.

What types of violations has LABORATORIOS SENOSIAIN SA DE CV received?

LABORATORIOS SENOSIAIN SA DE CV 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 LABORATORIOS SENOSIAIN SA DE CV come from?

All FDA import refusal data for LABORATORIOS SENOSIAIN 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.