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SELARL COTE D AZUR PHARMACY

⚠️ High Risk

FEI: 3041112665 • Nice, Alpes-Maritimes • FRANCE

FEI

FEI Number

3041112665

📍

Location

Nice, Alpes-Maritimes

🇫🇷

Country

FRANCE
🏢

Address

14 Rue De France, , Nice, Alpes-Maritimes, France

High Risk

FDA Import Risk Assessment

53.1
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

2
Total Refusals
2
Unique Violations
12/19/2025
Latest Refusal
12/19/2025
Earliest Refusal

Score Breakdown

Violation Severity
65.0×40%
Refusal Volume
17.7×30%
Recency
98.8×20%
Frequency
20.0×10%
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

1182×

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).

2372×

NO PMA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).

Refusal History

DateProductViolationsDivision
12/19/2025
79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
Division of Southeast Imports (DSEI)
12/19/2025
79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE
118NOT LISTED
237NO PMA
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is SELARL COTE D AZUR PHARMACY's FDA import refusal history?

SELARL COTE D AZUR PHARMACY (FEI: 3041112665) has 2 FDA import refusal record(s) in our database, spanning from 12/19/2025 to 12/19/2025.

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. SELARL COTE D AZUR PHARMACY's FEI number is 3041112665.

What types of violations has SELARL COTE D AZUR PHARMACY received?

SELARL COTE D AZUR PHARMACY 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 SELARL COTE D AZUR PHARMACY come from?

All FDA import refusal data for SELARL COTE D AZUR PHARMACY 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.