ImportRefusal LogoImportRefusal

Diamour Yvette

⚠️ Moderate Risk

FEI: 3007556949 • Port-Au-Prince, ouest • HAITI

FEI

FEI Number

3007556949

📍

Location

Port-Au-Prince, ouest

🇭🇹

Country

HAITI
🏢

Address

Martissant 7, , Port-Au-Prince, ouest, Haiti

Moderate Risk

FDA Import Risk Assessment

33.1
LowModerateHighCritical

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

Statistics

4
Total Refusals
5
Unique Violations
6/23/2009
Latest Refusal
6/23/2009
Earliest Refusal

Score Breakdown

Violation Severity
53.3×40%
Refusal Volume
25.9×30%
Recency
0.0×20%
Frequency
40.0×10%
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

4732×

LABELING

The article appears in violation of FPLA because of its placement, form and/or contents statement.

1971×

COSM COLOR

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).

3241×

NO ENGLISH

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(f) of the FD&C Act in that any word, statement, or other information required by or under the authority of the FD&C Act to appear on the label or labeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs, or devices, in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individual under customary terms of purchase and use (for example, label contains information in two or more languages but fails to repeat all required information in both languages in accordance with 21 CFR 101.15(c)(2), or label fails to include all required information in English in accordance with 21 CFR 101.15(c)(1), except in the case of articles distributed solely in the Commonwealth of Puerto Rico or in a Territory where the predominant language is one other than English)).

32601×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)

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
6/23/2009
53LC06MOISTURIZING (SKIN CARE PREPARATIONS)
3260NO ENGLISH
75UNAPPROVED
Florida District Office (FLA-DO)
6/23/2009
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
473LABELING
Florida District Office (FLA-DO)
6/23/2009
26CGT05PALM KERNEL OIL, REFINED, SINGLE INGREDIENT
324NO ENGLISH
Florida District Office (FLA-DO)
6/23/2009
53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)
197COSM COLOR
473LABELING
Florida District Office (FLA-DO)

Frequently Asked Questions

What is Diamour Yvette's FDA import refusal history?

Diamour Yvette (FEI: 3007556949) has 4 FDA import refusal record(s) in our database, spanning from 6/23/2009 to 6/23/2009.

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. Diamour Yvette's FEI number is 3007556949.

What types of violations has Diamour Yvette received?

Diamour Yvette has been cited for 5 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 Diamour Yvette come from?

All FDA import refusal data for Diamour Yvette 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.