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Pharmacia Nv/Sa

⚠️ Moderate Risk

FEI: 3004108392 • Puurs • BELGIUM

FEI

FEI Number

3004108392

📍

Location

Puurs

🇧🇪

Country

BELGIUM
🏢

Address

Marailles Polladon, , Puurs, , Belgium

Moderate Risk

FDA Import Risk Assessment

41.8
LowModerateHighCritical

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

Statistics

2
Total Refusals
1
Unique Violations
7/31/2009
Latest Refusal
3/29/2005
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
17.7×30%
Recency
0.0×20%
Frequency
4.6×10%
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

752×

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
7/31/2009
63BCA30THEOPHYLLINE (BRONCHODILATOR)
75UNAPPROVED
New Orleans District Office (NOL-DO)
3/29/2005
65JDP20MEDROGESTONE (PROGESTIN)
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Pharmacia Nv/Sa's FDA import refusal history?

Pharmacia Nv/Sa (FEI: 3004108392) has 2 FDA import refusal record(s) in our database, spanning from 3/29/2005 to 7/31/2009.

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 Nv/Sa's FEI number is 3004108392.

What types of violations has Pharmacia Nv/Sa received?

Pharmacia Nv/Sa 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 Nv/Sa come from?

All FDA import refusal data for Pharmacia Nv/Sa 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.