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Biotivia Bioceuticals International Srl

⚠️ Moderate Risk

FEI: 3008624803 • Verona, Vr • ITALY

FEI

FEI Number

3008624803

📍

Location

Verona, Vr

🇮🇹

Country

ITALY
🏢

Address

Via Carlo Cattaneo S N, , Verona, Vr, Italy

Moderate Risk

FDA Import Risk Assessment

32.3
LowModerateHighCritical

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

Statistics

1
Total Refusals
2
Unique Violations
12/31/2010
Latest Refusal
12/31/2010
Earliest Refusal

Score Breakdown

Violation Severity
70.0×40%
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

2601×

FALSE

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(a)(1 ) of the FD&C Act in that the labeling is false or misleading in any particular.

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
12/31/2010
54YBE99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C.
260FALSE
75UNAPPROVED
Los Angeles District Office (LOS-DO)

Frequently Asked Questions

What is Biotivia Bioceuticals International Srl's FDA import refusal history?

Biotivia Bioceuticals International Srl (FEI: 3008624803) has 1 FDA import refusal record(s) in our database, spanning from 12/31/2010 to 12/31/2010.

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. Biotivia Bioceuticals International Srl's FEI number is 3008624803.

What types of violations has Biotivia Bioceuticals International Srl received?

Biotivia Bioceuticals International Srl 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 Biotivia Bioceuticals International Srl come from?

All FDA import refusal data for Biotivia Bioceuticals International Srl 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.