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BR SAS

⚠️ Moderate Risk

FEI: 1000373305 • Suresnes • FRANCE

FEI

FEI Number

1000373305

📍

Location

Suresnes

🇫🇷

Country

FRANCE
🏢

Address

28 Rue De La Procession, , Suresnes, , France

Moderate Risk

FDA Import Risk Assessment

40.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
4/1/2013
Latest Refusal
6/21/2012
Earliest Refusal

Score Breakdown

Violation Severity
76.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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

162×

DIRECTIONS

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.

751×

UNAPPROVED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).

Refusal History

DateProductViolationsDivision
4/1/2013
53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
New Orleans District Office (NOL-DO)
6/21/2012
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
New York District Office (NYK-DO)
6/21/2012
66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC.
16DIRECTIONS
New York District Office (NYK-DO)

Frequently Asked Questions

What is BR SAS's FDA import refusal history?

BR SAS (FEI: 1000373305) has 3 FDA import refusal record(s) in our database, spanning from 6/21/2012 to 4/1/2013.

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. BR SAS's FEI number is 1000373305.

What types of violations has BR SAS received?

BR SAS 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 BR SAS come from?

All FDA import refusal data for BR SAS 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.