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SANOFI

⚠️ Moderate Risk

FEI: 3017135599 • Taguig Metro Manila • PHILIPPINES

FEI

FEI Number

3017135599

📍

Location

Taguig Metro Manila

🇵🇭
🏢

Address

21st 22nd And 23rd Flrs, , Taguig Metro Manila, , Philippines

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

1
Total Refusals
1
Unique Violations
8/9/2024
Latest Refusal
8/9/2024
Earliest Refusal

Score Breakdown

Violation Severity
50.0×40%
Refusal Volume
11.2×30%
Recency
71.2×20%
Frequency
10.0×10%
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

32801×

FRNMFGREG

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
8/9/2024
61LCY38CLOPIDOGREL BISULFATE (ANTI-COAGULANT)
3280FRNMFGREG
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is SANOFI's FDA import refusal history?

SANOFI (FEI: 3017135599) has 1 FDA import refusal record(s) in our database, spanning from 8/9/2024 to 8/9/2024.

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. SANOFI's FEI number is 3017135599.

What types of violations has SANOFI received?

SANOFI has been cited for 1 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 SANOFI come from?

All FDA import refusal data for SANOFI 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.