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FIRMA TRIWORX

⚠️ Moderate Risk

FEI: 3014525411 • Wampersdorf, Niederosterreich • AUSTRIA

FEI

FEI Number

3014525411

📍

Location

Wampersdorf, Niederosterreich

🇦🇹

Country

AUSTRIA
🏢

Address

Obere Hauptstrase 33, , Wampersdorf, Niederosterreich, Austria

Moderate Risk

FDA Import Risk Assessment

27.0
LowModerateHighCritical

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

Statistics

1
Total Refusals
3
Unique Violations
3/8/2019
Latest Refusal
3/8/2019
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
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

2181×

LIST INGRE

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it appears to be misbranded within the meaning of Section 403(i)(2) of the FD&C Act in that it is fabricated from two or more ingredients and the label fails to bear the common or usual name of each such ingredient and/or the article purports to be a beverage containing vegetable or fruit juice, but does not bear a statement with appropriate prominence on the information panel of the total percentage of such fruit or vegetable juice contained in the food.

23001×

DIETARYLBL

The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.

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
3/8/2019
54YCL99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
218LIST INGRE
2300DIETARYLBL
75UNAPPROVED
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is FIRMA TRIWORX's FDA import refusal history?

FIRMA TRIWORX (FEI: 3014525411) has 1 FDA import refusal record(s) in our database, spanning from 3/8/2019 to 3/8/2019.

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. FIRMA TRIWORX's FEI number is 3014525411.

What types of violations has FIRMA TRIWORX received?

FIRMA TRIWORX 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 FIRMA TRIWORX come from?

All FDA import refusal data for FIRMA TRIWORX 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.