ImportRefusal LogoImportRefusal

Trans Bussan S.A.

⚠️ Moderate Risk

FEI: 1000201468 • Geneva 15, Geneva • SWITZERLAND

FEI

FEI Number

1000201468

📍

Location

Geneva 15, Geneva

🇨🇭
🏢

Address

Rue Michel-Servet 12, Case Postale 352, Geneva 15, Geneva, Switzerland

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
2
Unique Violations
10/11/2001
Latest Refusal
10/11/2001
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).

781×

STERILITY

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.

Refusal History

DateProductViolationsDivision
10/11/2001
66VIY99MISCELLANEOUS PATENT MEDICINES, ETC.
75UNAPPROVED
78STERILITY
Detroit District Office (DET-DO)

Frequently Asked Questions

What is Trans Bussan S.A.'s FDA import refusal history?

Trans Bussan S.A. (FEI: 1000201468) has 1 FDA import refusal record(s) in our database, spanning from 10/11/2001 to 10/11/2001.

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. Trans Bussan S.A.'s FEI number is 1000201468.

What types of violations has Trans Bussan S.A. received?

Trans Bussan S.A. 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 Trans Bussan S.A. come from?

All FDA import refusal data for Trans Bussan S.A. 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.