ImportRefusal LogoImportRefusal

Sanofi-Synthelabo Phils. Inc.

⚠️ Moderate Risk

FEI: 3003819155 • Makati, National Capital Region • PHILIPPINES

FEI

FEI Number

3003819155

📍

Location

Makati, National Capital Region

🇵🇭
🏢

Address

108 Herrera Street, City, Makati, National Capital Region, Philippines

Moderate Risk

FDA Import Risk Assessment

40.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
1
Unique Violations
2/5/2013
Latest Refusal
2/5/2013
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
11.2×30%
Recency
0.0×20%
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

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
2/5/2013
53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Sanofi-Synthelabo Phils. Inc.'s FDA import refusal history?

Sanofi-Synthelabo Phils. Inc. (FEI: 3003819155) has 1 FDA import refusal record(s) in our database, spanning from 2/5/2013 to 2/5/2013.

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. Sanofi-Synthelabo Phils. Inc.'s FEI number is 3003819155.

What types of violations has Sanofi-Synthelabo Phils. Inc. received?

Sanofi-Synthelabo Phils. Inc. 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-Synthelabo Phils. Inc. come from?

All FDA import refusal data for Sanofi-Synthelabo Phils. Inc. 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.