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Union-Swiss

⚠️ Moderate Risk

FEI: 3009403422 • Middlesmiddles • SOUTH AFRICA

FEI

FEI Number

3009403422

📍

Location

Middlesmiddles

🇿🇦
🏢

Address

P.O.Box 232, , Middlesmiddles, , South Africa

Moderate Risk

FDA Import Risk Assessment

28.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
5/11/2012
Latest Refusal
5/11/2012
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
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

3301×

UNSAFE COL

The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).

3361×

INCONSPICU

Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Refusal History

DateProductViolationsDivision
5/11/2012
66VAY99MISCELLANEOUS PATENT MEDICINES, ETC.
330UNSAFE COL
336INCONSPICU
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Union-Swiss's FDA import refusal history?

Union-Swiss (FEI: 3009403422) has 1 FDA import refusal record(s) in our database, spanning from 5/11/2012 to 5/11/2012.

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. Union-Swiss's FEI number is 3009403422.

What types of violations has Union-Swiss received?

Union-Swiss 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 Union-Swiss come from?

All FDA import refusal data for Union-Swiss 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.