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Myvitaly

⚠️ Moderate Risk

FEI: 3014093296 • Montebelluna, Treviso • ITALY

FEI

FEI Number

3014093296

📍

Location

Montebelluna, Treviso

🇮🇹

Country

ITALY
🏢

Address

Piazza Vienna 5, , Montebelluna, Treviso, Italy

Moderate Risk

FDA Import Risk Assessment

35.9
LowModerateHighCritical

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

Statistics

6
Total Refusals
2
Unique Violations
1/7/2022
Latest Refusal
11/17/2020
Earliest Refusal

Score Breakdown

Violation Severity
43.3×40%
Refusal Volume
31.3×30%
Recency
19.8×20%
Frequency
52.6×10%
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

1184×

NOT LISTED

It appears the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by section 510(j) or 510(k).

38732×

708NOREG

It has been determined the drug was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.

Refusal History

DateProductViolationsDivision
1/7/2022
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
118NOT LISTED
Division of Southeast Imports (DSEI)
1/7/2022
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
118NOT LISTED
Division of Southeast Imports (DSEI)
1/7/2022
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
118NOT LISTED
Division of Southeast Imports (DSEI)
1/7/2022
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
118NOT LISTED
Division of Southeast Imports (DSEI)
11/17/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
3873708NOREG
Division of Southeast Imports (DSEI)
11/17/2020
62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL)
3873708NOREG
Division of Southeast Imports (DSEI)

Frequently Asked Questions

What is Myvitaly's FDA import refusal history?

Myvitaly (FEI: 3014093296) has 6 FDA import refusal record(s) in our database, spanning from 11/17/2020 to 1/7/2022.

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. Myvitaly's FEI number is 3014093296.

What types of violations has Myvitaly received?

Myvitaly 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 Myvitaly come from?

All FDA import refusal data for Myvitaly 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.