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Pall Biosepra Sa

✅ Low Risk

FEI: 3005069932 • Cergy, Val d'Oise • FRANCE

FEI

FEI Number

3005069932

📍

Location

Cergy, Val d'Oise

🇫🇷

Country

FRANCE
🏢

Address

48 Avenue Des Genottes, , Cergy, Val d'Oise, France

Low Risk

FDA Import Risk Assessment

18.3
LowModerateHighCritical

This firm has a minimal history of FDA import refusals with low-severity violations.

Statistics

1
Total Refusals
2
Unique Violations
9/1/2009
Latest Refusal
9/1/2009
Earliest Refusal

Score Breakdown

Violation Severity
35.0×40%
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

3331×

LACKS FIRM

The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
9/1/2009
65PCA02SILDENAFIL CITRATE (REGULATOR)
333LACKS FIRM
483DRUG NAME
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Pall Biosepra Sa's FDA import refusal history?

Pall Biosepra Sa (FEI: 3005069932) has 1 FDA import refusal record(s) in our database, spanning from 9/1/2009 to 9/1/2009.

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. Pall Biosepra Sa's FEI number is 3005069932.

What types of violations has Pall Biosepra Sa received?

Pall Biosepra Sa 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 Pall Biosepra Sa come from?

All FDA import refusal data for Pall Biosepra 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.