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LABORATORIO ALPHARMA SA DE CV

⚠️ Moderate Risk

FEI: 3012751609 • Hidalgo, Nuevo Leon • MEXICO

FEI

FEI Number

3012751609

📍

Location

Hidalgo, Nuevo Leon

🇲🇽

Country

MEXICO
🏢

Address

Boulevard Pipla No 11 E, Col. MIGUEL HIDALGO, Hidalgo, Nuevo Leon, 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
2/14/2018
Latest Refusal
2/14/2018
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
2/14/2018
62GCY94KETOROLAC TROMETHAMINE (ANTI-INFLAMMATORY)
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is LABORATORIO ALPHARMA SA DE CV's FDA import refusal history?

LABORATORIO ALPHARMA SA DE CV (FEI: 3012751609) has 1 FDA import refusal record(s) in our database, spanning from 2/14/2018 to 2/14/2018.

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. LABORATORIO ALPHARMA SA DE CV's FEI number is 3012751609.

What types of violations has LABORATORIO ALPHARMA SA DE CV received?

LABORATORIO ALPHARMA 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 LABORATORIO ALPHARMA SA DE CV come from?

All FDA import refusal data for LABORATORIO ALPHARMA 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.