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Zonaverde Cosmetics

⚠️ High Risk

FEI: 3008102113 • Winnipeg, MANITOBA • CANADA

FEI

FEI Number

3008102113

📍

Location

Winnipeg, MANITOBA

🇨🇦

Country

CANADA
🏢

Address

1203 Richard Ave, , Winnipeg, MANITOBA, Canada

High Risk

FDA Import Risk Assessment

58.0
LowModerateHighCritical

This firm has a significant history of FDA import refusals with notable violations.

Statistics

11
Total Refusals
1
Unique Violations
4/26/2010
Latest Refusal
4/26/2010
Earliest Refusal

Score Breakdown

Violation Severity
90.0×40%
Refusal Volume
40.0×30%
Recency
0.0×20%
Frequency
100.0×10%
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

7511×

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
4/26/2010
53CD04EYE LOTION (EYE MAKEUP PREPARATIONS)
75UNAPPROVED
Minneapolis District Office (MIN-DO)
4/26/2010
53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
75UNAPPROVED
Minneapolis District Office (MIN-DO)
4/26/2010
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
Minneapolis District Office (MIN-DO)
4/26/2010
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
Minneapolis District Office (MIN-DO)
4/26/2010
53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Minneapolis District Office (MIN-DO)
4/26/2010
53LD10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Minneapolis District Office (MIN-DO)
4/26/2010
53LD07NIGHT (SKIN CARE PREPARATIONS)
75UNAPPROVED
Minneapolis District Office (MIN-DO)
4/26/2010
53LD06MOISTURIZING (SKIN CARE PREPARATIONS)
75UNAPPROVED
Minneapolis District Office (MIN-DO)
4/26/2010
53LD03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS)
75UNAPPROVED
Minneapolis District Office (MIN-DO)
4/26/2010
53LD99OTHER SKIN CARE PREPARATIONS, N.E.C.
75UNAPPROVED
Minneapolis District Office (MIN-DO)
4/26/2010
53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS)
75UNAPPROVED
Minneapolis District Office (MIN-DO)

Frequently Asked Questions

What is Zonaverde Cosmetics's FDA import refusal history?

Zonaverde Cosmetics (FEI: 3008102113) has 11 FDA import refusal record(s) in our database, spanning from 4/26/2010 to 4/26/2010.

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. Zonaverde Cosmetics's FEI number is 3008102113.

What types of violations has Zonaverde Cosmetics received?

Zonaverde Cosmetics has been cited for 1 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 Zonaverde Cosmetics come from?

All FDA import refusal data for Zonaverde Cosmetics 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.