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Groupe Panther Sa

⚠️ Moderate Risk

FEI: 3004035851 • St Ouen, Seine Saint Denis • FRANCE

FEI

FEI Number

3004035851

📍

Location

St Ouen, Seine Saint Denis

🇫🇷

Country

FRANCE
🏢

Address

155 rue du Docteur Bauer, , St Ouen, Seine Saint Denis, France

Moderate Risk

FDA Import Risk Assessment

38.6
LowModerateHighCritical

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

Statistics

8
Total Refusals
2
Unique Violations
6/19/2012
Latest Refusal
6/19/2012
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
35.3×30%
Recency
0.0×20%
Frequency
80.0×10%
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

1188×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

4838×

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
6/19/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
483DRUG NAME
Florida District Office (FLA-DO)
6/19/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
483DRUG NAME
Florida District Office (FLA-DO)
6/19/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
483DRUG NAME
Florida District Office (FLA-DO)
6/19/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
483DRUG NAME
Florida District Office (FLA-DO)
6/19/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
483DRUG NAME
Florida District Office (FLA-DO)
6/19/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
483DRUG NAME
Florida District Office (FLA-DO)
6/19/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
483DRUG NAME
Florida District Office (FLA-DO)
6/19/2012
66VDY99MISCELLANEOUS PATENT MEDICINES, ETC.
118NOT LISTED
483DRUG NAME
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Groupe Panther Sa's FDA import refusal history?

Groupe Panther Sa (FEI: 3004035851) has 8 FDA import refusal record(s) in our database, spanning from 6/19/2012 to 6/19/2012.

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. Groupe Panther Sa's FEI number is 3004035851.

What types of violations has Groupe Panther Sa received?

Groupe Panther 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 Groupe Panther Sa come from?

All FDA import refusal data for Groupe Panther 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.