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PHARMACIA UPJOHN SA DE CV

⚠️ Moderate Risk

FEI: 3013053898 • Toluca • MEXICO

FEI

FEI Number

3013053898

📍

Location

Toluca

🇲🇽

Country

MEXICO
🏢

Address

Calle 1 sur Lote NO 12, , Toluca, , Mexico

Moderate Risk

FDA Import Risk Assessment

45.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
1
Unique Violations
5/8/2018
Latest Refusal
3/23/2017
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
26.6×10%
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

753×

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
5/8/2018
62LCJ52PERMETHRIN (ANTI-PROTOZOAL, A-LEISHMANIAL, ANTI-MALARIAL)
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/31/2017
61ECL04BUDESONIDE (ANTI-ASTHMATIC)
75UNAPPROVED
Division of Southeast Imports (DSEI)
3/23/2017
61ECY04BUDESONIDE (ANTI-ASTHMATIC)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is PHARMACIA UPJOHN SA DE CV's FDA import refusal history?

PHARMACIA UPJOHN SA DE CV (FEI: 3013053898) has 3 FDA import refusal record(s) in our database, spanning from 3/23/2017 to 5/8/2018.

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. PHARMACIA UPJOHN SA DE CV's FEI number is 3013053898.

What types of violations has PHARMACIA UPJOHN SA DE CV received?

PHARMACIA UPJOHN 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 PHARMACIA UPJOHN SA DE CV come from?

All FDA import refusal data for PHARMACIA UPJOHN 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.