ORGANIC NAILS

⚠️ High Risk

FEI: 3008757774 • Zapopan, Jalisco • MEXICO

FEI

FEI Number

3008757774

📍

Location

Zapopan, Jalisco

🇲🇽

Country

MEXICO

🏢

Address

Circuito Angel Romero 330, Fracc. LOMAS DEL COLLI, Zapopan, Jalisco, Mexico

High Risk

FDA Import Risk Assessment

66.5

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

7/3/2024

Latest Refusal

3/3/2015

Earliest Refusal

Score Breakdown

Violation Severity

66.2×40%

Refusal Volume

65.9×30%

Recency

69.5×20%

Frequency

63.1×10%

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

19746×

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).

47121×

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.

388110×

COSMETFPLA

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain an undeclared color additive which renders it misbranded within the meaning of Sections 1454(c)(3)(B) and 1456 of the Fair Packaging and Labeling Act.

4758×

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.

1983×

COLOR LBLG

The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.

4741×

COSMETLBLG

It appears the label does not bear the common or usual name of the cosmetic.

Refusal History

Date	Product	Violations	Division
7/3/2024	53HY99OTHER MANICURING PREPARATIONS, N.E.C.	471CSTIC LBLG	Division of Southeast Imports (DSEI)
5/15/2024	53HY99OTHER MANICURING PREPARATIONS, N.E.C.	3881COSMETFPLA	Division of Southeast Imports (DSEI)
4/8/2024	53HY99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
4/8/2024	53HY99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
4/8/2024	53HY99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
4/8/2024	53HY99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
2/2/2024	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	3881COSMETFPLA	Division of Southwest Imports (DSWI)
2/2/2024	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southwest Imports (DSWI)
12/13/2023	53HY99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
11/6/2023	53HY99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
9/7/2023	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR 3881COSMETFPLA	Division of Southwest Imports (DSWI)
9/7/2023	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR 3881COSMETFPLA	Division of Southwest Imports (DSWI)
9/7/2023	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR 3881COSMETFPLA	Division of Southwest Imports (DSWI)
9/7/2023	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR 3881COSMETFPLA	Division of Southwest Imports (DSWI)
7/20/2023	53HY99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR 3881COSMETFPLA	Division of Southeast Imports (DSEI)
6/15/2023	53HY99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
6/15/2023	53HY99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
6/15/2023	53HY99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
4/27/2023	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR 3881COSMETFPLA	Division of Southeast Imports (DSEI)
4/27/2023	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR 3881COSMETFPLA	Division of Southeast Imports (DSEI)
7/1/2022	53HH99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
10/6/2021	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
7/29/2021	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR 3881COSMETFPLA	Division of Southeast Imports (DSEI)
7/21/2021	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
7/21/2021	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
7/21/2021	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
2/12/2021	53HD03NAIL CREAMS AND LOTIONS (MANICURING PREPARATIONS)	197COSM COLOR	Division of Southeast Imports (DSEI)
2/12/2021	53HD03NAIL CREAMS AND LOTIONS (MANICURING PREPARATIONS)	197COSM COLOR	Division of Southeast Imports (DSEI)
2/12/2021	53HD03NAIL CREAMS AND LOTIONS (MANICURING PREPARATIONS)	197COSM COLOR	Division of Southeast Imports (DSEI)
12/11/2020	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR 471CSTIC LBLG 475COSMETLBLG	Division of Southwest Imports (DSWI)
12/11/2020	53HH99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR 471CSTIC LBLG 475COSMETLBLG	Division of Southwest Imports (DSWI)
7/25/2018	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
7/25/2018	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR	Division of Southeast Imports (DSEI)
6/8/2016	53HH05NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS)	471CSTIC LBLG	New Orleans District Office (NOL-DO)
6/8/2016	53HH05NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS)	471CSTIC LBLG	New Orleans District Office (NOL-DO)
6/8/2016	53HH05NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS)	197COSM COLOR 471CSTIC LBLG	New Orleans District Office (NOL-DO)
6/8/2016	53HC05NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS)	197COSM COLOR 471CSTIC LBLG	New Orleans District Office (NOL-DO)
5/23/2016	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	471CSTIC LBLG 475COSMETLBLG	Division of Southeast Imports (DSEI)
5/23/2016	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	471CSTIC LBLG 475COSMETLBLG	Division of Southeast Imports (DSEI)
5/23/2016	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	471CSTIC LBLG 475COSMETLBLG	Division of Southeast Imports (DSEI)
5/23/2016	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	471CSTIC LBLG 475COSMETLBLG	Division of Southeast Imports (DSEI)
5/23/2016	53PD99OTHER COSMETIC RAW MATERIALS, N.E.C.	471CSTIC LBLG 475COSMETLBLG	Division of Southeast Imports (DSEI)
5/23/2016	53PD99OTHER COSMETIC RAW MATERIALS, N.E.C.	471CSTIC LBLG	Division of Southeast Imports (DSEI)
5/23/2016	53PD99OTHER COSMETIC RAW MATERIALS, N.E.C.	471CSTIC LBLG	Division of Southeast Imports (DSEI)
4/14/2016	53PD99OTHER COSMETIC RAW MATERIALS, N.E.C.	471CSTIC LBLG 474COSMETLBLG	Division of Southeast Imports (DSEI)
4/14/2016	53HY99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR 471CSTIC LBLG	Division of Southeast Imports (DSEI)
4/14/2016	53HD04NAIL EXTENDERS (MANICURING PREPARATIONS)	197COSM COLOR 198COLOR LBLG 471CSTIC LBLG	Division of Southeast Imports (DSEI)
4/14/2016	53HD04NAIL EXTENDERS (MANICURING PREPARATIONS)	197COSM COLOR 198COLOR LBLG 471CSTIC LBLG	Division of Southeast Imports (DSEI)
4/14/2016	53HD04NAIL EXTENDERS (MANICURING PREPARATIONS)	197COSM COLOR 198COLOR LBLG 471CSTIC LBLG	Division of Southeast Imports (DSEI)
4/14/2016	53HD04NAIL EXTENDERS (MANICURING PREPARATIONS)	197COSM COLOR	Division of Southeast Imports (DSEI)
3/17/2016	53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C.	197COSM COLOR 471CSTIC LBLG	Cincinnati District Office (CIN-DO)
2/16/2016	53HD06NAIL POLISH AND ENAMEL REMOVERS (MANICURING PREPARATIONS)	197COSM COLOR	Division of Southeast Imports (DSEI)
2/16/2016	53HD06NAIL POLISH AND ENAMEL REMOVERS (MANICURING PREPARATIONS)	197COSM COLOR	Division of Southeast Imports (DSEI)
2/16/2016	53HD06NAIL POLISH AND ENAMEL REMOVERS (MANICURING PREPARATIONS)	197COSM COLOR	Division of Southeast Imports (DSEI)
2/16/2016	53HD06NAIL POLISH AND ENAMEL REMOVERS (MANICURING PREPARATIONS)	197COSM COLOR	Division of Southeast Imports (DSEI)
2/16/2016	53HD06NAIL POLISH AND ENAMEL REMOVERS (MANICURING PREPARATIONS)	197COSM COLOR	Division of Southeast Imports (DSEI)
2/16/2016	53HD06NAIL POLISH AND ENAMEL REMOVERS (MANICURING PREPARATIONS)	197COSM COLOR	Division of Southeast Imports (DSEI)
12/14/2015	53HD05NAIL POLISH AND ENAMEL (MANICURING PREPARATIONS)	197COSM COLOR	Division of Southeast Imports (DSEI)
3/3/2015	53HD99OTHER MANICURING PREPARATIONS, N.E.C.	197COSM COLOR 471CSTIC LBLG 475COSMETLBLG	Southwest Import District Office (SWI-DO)

Frequently Asked Questions

What is ORGANIC NAILS's FDA import refusal history?

ORGANIC NAILS (FEI: 3008757774) has 59 FDA import refusal record(s) in our database, spanning from 3/3/2015 to 7/3/2024.

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. ORGANIC NAILS's FEI number is 3008757774.

What types of violations has ORGANIC NAILS received?

ORGANIC NAILS has been cited for 6 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 ORGANIC NAILS come from?

All FDA import refusal data for ORGANIC NAILS 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.