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Trybol AG

⚠️ Moderate Risk

FEI: 1000555714 • Neuhausen Am Rheinfall, Schaffhausen • SWITZERLAND

FEI

FEI Number

1000555714

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Location

Neuhausen Am Rheinfall, Schaffhausen

🇨🇭
🏢

Address

Rheinstrasse 86, , Neuhausen Am Rheinfall, Schaffhausen, Switzerland

Moderate Risk

FDA Import Risk Assessment

31.9
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
8/17/2022
Latest Refusal
8/17/2022
Earliest Refusal

Score Breakdown

Violation Severity
60.0×40%
Refusal Volume
11.2×30%
Recency
17.9×20%
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

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

3441×

WARNINGS

It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.

4831×

DRUG NAME

The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.

Refusal History

DateProductViolationsDivision
8/17/2022
63RBG06STANNOUS FLUORIDE (DENTAL CARIES PROPHYLACTIC)
335LACKS N/C
344WARNINGS
483DRUG NAME
Division of Northeast Imports (DNEI)

Frequently Asked Questions

What is Trybol AG's FDA import refusal history?

Trybol AG (FEI: 1000555714) has 1 FDA import refusal record(s) in our database, spanning from 8/17/2022 to 8/17/2022.

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. Trybol AG's FEI number is 1000555714.

What types of violations has Trybol AG received?

Trybol AG has been cited for 3 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 Trybol AG come from?

All FDA import refusal data for Trybol AG 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.