ImportRefusal LogoImportRefusal

GLAXOSMITHKLINE MEXICO SA DE CV

⚠️ Moderate Risk

FEI: 3012393035 • Mexico • MEXICO

FEI

FEI Number

3012393035

📍

Location

Mexico

🇲🇽

Country

MEXICO
🏢

Address

Calz Mexico-Xochimilco, , Mexico, , Mexico

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
12/23/2016
Latest Refusal
12/23/2016
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
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

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
12/23/2016
56YCA99ANTIBIOTIC N.E.C.
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is GLAXOSMITHKLINE MEXICO SA DE CV's FDA import refusal history?

GLAXOSMITHKLINE MEXICO SA DE CV (FEI: 3012393035) has 1 FDA import refusal record(s) in our database, spanning from 12/23/2016 to 12/23/2016.

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. GLAXOSMITHKLINE MEXICO SA DE CV's FEI number is 3012393035.

What types of violations has GLAXOSMITHKLINE MEXICO SA DE CV received?

GLAXOSMITHKLINE MEXICO SA DE CV has been cited for 1 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 GLAXOSMITHKLINE MEXICO SA DE CV come from?

All FDA import refusal data for GLAXOSMITHKLINE MEXICO 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.