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Lorigin Cosmetics

⚠️ Moderate Risk

FEI: 3009512294 • Dubai • UNITED ARAB EMIRATES

FEI

FEI Number

3009512294

📍

Location

Dubai

🇦🇪
🏢

Address

Safz Sharja H, , Dubai, , United Arab Emirates

Moderate Risk

FDA Import Risk Assessment

35.0
LowModerateHighCritical

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

Statistics

6
Total Refusals
8
Unique Violations
7/3/2012
Latest Refusal
5/22/2012
Earliest Refusal

Score Breakdown

Violation Severity
49.1×40%
Refusal Volume
31.3×30%
Recency
0.0×20%
Frequency
60.0×10%
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

4712×

CSTIC LBLG

The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.

4722×

NO ENGLISH

Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).

752×

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).

3201×

LACKS FIRM

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(e)(1) of the FD&C Act in that the food is in package form and the label fails to bear the name and place of business of the manufacturer, packer, or distributor.

111×

UNSAFE COL

The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).

3211×

LACKS N/C

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(e)(2) of the FD&C Act in that the food is in package form and the label fails to bear an accurate statement of the quantity of the contents in terms of weight, measure, or numerical count in accordance with Section 403(e)(2) of the FD&C Act.

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.

2561×

INCONSPICU

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)).

Refusal History

DateProductViolationsDivision
7/3/2012
53LC99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
New Orleans District Office (NOL-DO)
6/11/2012
50NGY18HENNA
11UNSAFE COL
New Orleans District Office (NOL-DO)
6/11/2012
53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS)
471CSTIC LBLG
New Orleans District Office (NOL-DO)
6/11/2012
07YET99SNACK FOODS NOT ELSEWHERE MENTIONED, N.E.C.
218LIST INGRE
256INCONSPICU
320LACKS FIRM
321LACKS N/C
New Orleans District Office (NOL-DO)
5/25/2012
62SBY99ANTI-SEBORRHEIC N.E.C.
472NO ENGLISH
75UNAPPROVED
New Orleans District Office (NOL-DO)
5/22/2012
62SBY99ANTI-SEBORRHEIC N.E.C.
472NO ENGLISH
75UNAPPROVED
New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Lorigin Cosmetics's FDA import refusal history?

Lorigin Cosmetics (FEI: 3009512294) has 6 FDA import refusal record(s) in our database, spanning from 5/22/2012 to 7/3/2012.

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. Lorigin Cosmetics's FEI number is 3009512294.

What types of violations has Lorigin Cosmetics received?

Lorigin Cosmetics has been cited for 8 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 Lorigin Cosmetics come from?

All FDA import refusal data for Lorigin 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.