Sarl Biogenie Beaute Concept

⚠️ Moderate Risk

FEI: 3002891113 • La Rochefoucauld, Charente • FRANCE

FEI

FEI Number

3002891113

📍

Location

La Rochefoucauld, Charente

🇫🇷

Country

FRANCE

🏢

Address

1 Chemin Du Rail, , La Rochefoucauld, Charente, France

Moderate Risk

FDA Import Risk Assessment

36.4

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

11/28/2005

Latest Refusal

12/22/2004

Earliest Refusal

Score Breakdown

Violation Severity

48.5×40%

Refusal Volume

33.5×30%

Recency

0.0×20%

Frequency

70.0×10%

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

1185×

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).

3414×

REGISTERED

It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).

4762×

NO REGISTR

The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).

5082×

NO 510(K)

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.

Refusal History

Date	Product	Violations	Division
11/28/2005	80LDQDEVICE, GENERAL MEDICAL	118NOT LISTED 341REGISTERED 476NO REGISTR 508NO 510(K)	Southwest Import District Office (SWI-DO)
11/28/2005	80LDQDEVICE, GENERAL MEDICAL	118NOT LISTED 341REGISTERED 476NO REGISTR 508NO 510(K)	Southwest Import District Office (SWI-DO)
12/22/2004	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED	Los Angeles District Office (LOS-DO)
12/22/2004	80LDQDEVICE, GENERAL MEDICAL	341REGISTERED	Los Angeles District Office (LOS-DO)
12/22/2004	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
12/22/2004	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)
12/22/2004	53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.	118NOT LISTED	Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Sarl Biogenie Beaute Concept's FDA import refusal history?

Sarl Biogenie Beaute Concept (FEI: 3002891113) has 7 FDA import refusal record(s) in our database, spanning from 12/22/2004 to 11/28/2005.

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. Sarl Biogenie Beaute Concept's FEI number is 3002891113.

What types of violations has Sarl Biogenie Beaute Concept received?

Sarl Biogenie Beaute Concept has been cited for 4 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 Sarl Biogenie Beaute Concept come from?

All FDA import refusal data for Sarl Biogenie Beaute Concept 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.