EQUIDERM

⚠️ Moderate Risk

FEI: 3025591186 • Aulnay-Sous-Bois, Seine-Saint-Denis • FRANCE

FEI

FEI Number

3025591186

📍

Location

Aulnay-Sous-Bois, Seine-Saint-Denis

🇫🇷

Country

FRANCE

🏢

Address

8 Rue Nicolas Robert, , Aulnay-Sous-Bois, Seine-Saint-Denis, France

Moderate Risk

FDA Import Risk Assessment

45.7

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

2/9/2024

Latest Refusal

2/9/2024

Earliest Refusal

Score Breakdown

Violation Severity

45.0×40%

Refusal Volume

31.3×30%

Recency

61.6×20%

Frequency

60.0×10%

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

Violation Summary

23806×

NO PMA/PDP

The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).

39046×

3904

Refusal History

Date	Product	Violations	Division
2/9/2024	79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE	2380NO PMA/PDP 39043904	Division of Northeast Imports (DNEI)
2/9/2024	79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE	2380NO PMA/PDP 39043904	Division of Northeast Imports (DNEI)
2/9/2024	79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE	2380NO PMA/PDP 39043904	Division of Northeast Imports (DNEI)
2/9/2024	79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE	2380NO PMA/PDP 39043904	Division of Northeast Imports (DNEI)
2/9/2024	79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE	2380NO PMA/PDP 39043904	Division of Northeast Imports (DNEI)
2/9/2024	79LMHIMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE	2380NO PMA/PDP 39043904	Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is EQUIDERM's FDA import refusal history?

EQUIDERM (FEI: 3025591186) has 6 FDA import refusal record(s) in our database, spanning from 2/9/2024 to 2/9/2024.

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. EQUIDERM's FEI number is 3025591186.

What types of violations has EQUIDERM received?

EQUIDERM 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 EQUIDERM come from?

All FDA import refusal data for EQUIDERM 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.