Najafi Cosmetics Co. Llc

⚠️ Moderate Risk

FEI: 3004605392 • Dubai • UNITED ARAB EMIRATES

FEI

FEI Number

3004605392

📍

Location

Dubai

🇦🇪

Country

UNITED ARAB EMIRATES

🏢

Address

Near Sina Al Buteen, , Dubai, , United Arab Emirates

Moderate Risk

FDA Import Risk Assessment

38.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

9/26/2019

Latest Refusal

8/5/2011

Earliest Refusal

Score Breakdown

Violation Severity

57.2×40%

Refusal Volume

44.6×30%

Recency

0.0×20%

Frequency

18.4×10%

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

Violation Summary

47310×

LABELING

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

4718×

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.

1977×

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).

755×

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).

4753×

COSMETLBLG

It appears that the cosmetic consists of two or more ingredients and the label does not list the common or usual name of each ingredient.

1182×

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).

3351×

LACKS N/C

The article is in package form and appears to not have a label containing an accurate statement of the quantity of the contents in terms of weight, measure or numerical count and no variations or exemptions have been prescribed by regs.

Refusal History

Date	Product	Violations	Division
9/26/2019	53CH02EYELINER (EYE MAKEUP PREPARATIONS)	473LABELING 475COSMETLBLG	Division of Northern Border Imports (DNBI)
9/26/2019	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING	Division of Northern Border Imports (DNBI)
9/26/2019	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING	Division of Northern Border Imports (DNBI)
9/26/2019	53JY99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C.	197COSM COLOR 473LABELING	Division of Northern Border Imports (DNBI)
9/26/2019	53JY01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	197COSM COLOR 471CSTIC LBLG 473LABELING 475COSMETLBLG	Division of Northern Border Imports (DNBI)
9/26/2019	53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.	197COSM COLOR 471CSTIC LBLG 473LABELING 475COSMETLBLG	Division of Northern Border Imports (DNBI)
9/26/2019	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	197COSM COLOR 471CSTIC LBLG 473LABELING	Division of Northern Border Imports (DNBI)
9/26/2019	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	197COSM COLOR 471CSTIC LBLG 473LABELING	Division of Northern Border Imports (DNBI)
9/26/2019	53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	197COSM COLOR 471CSTIC LBLG 473LABELING	Division of Northern Border Imports (DNBI)
9/26/2019	53JD99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C.	197COSM COLOR 471CSTIC LBLG 473LABELING	Division of Northern Border Imports (DNBI)
9/26/2019	60LBJ99ANALGESIC, N.E.C.	75UNAPPROVED	Division of Northern Border Imports (DNBI)
9/26/2019	66VBL99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Division of Northern Border Imports (DNBI)
9/26/2019	66VBY99MISCELLANEOUS PATENT MEDICINES, ETC.	75UNAPPROVED	Division of Northern Border Imports (DNBI)
8/5/2011	66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 335LACKS N/C 75UNAPPROVED	New Orleans District Office (NOL-DO)
8/5/2011	66VBU99MISCELLANEOUS PATENT MEDICINES, ETC.	118NOT LISTED 75UNAPPROVED	New Orleans District Office (NOL-DO)

Frequently Asked Questions

What is Najafi Cosmetics Co. Llc's FDA import refusal history?

Najafi Cosmetics Co. Llc (FEI: 3004605392) has 15 FDA import refusal record(s) in our database, spanning from 8/5/2011 to 9/26/2019.

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. Najafi Cosmetics Co. Llc's FEI number is 3004605392.

What types of violations has Najafi Cosmetics Co. Llc received?

Najafi Cosmetics Co. Llc has been cited for 7 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 Najafi Cosmetics Co. Llc come from?

All FDA import refusal data for Najafi Cosmetics Co. Llc 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.