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Huilarome Sarl

⚠️ Moderate Risk

FEI: 3011744876 • Marrakech • MOROCCO

FEI

FEI Number

3011744876

📍

Location

Marrakech

🇲🇦

Country

MOROCCO
🏢

Address

257 Qi Sidi Ghanem, , Marrakech, , Morocco

Moderate Risk

FDA Import Risk Assessment

32.4
LowModerateHighCritical

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

Statistics

3
Total Refusals
2
Unique Violations
9/16/2016
Latest Refusal
8/1/2016
Earliest Refusal

Score Breakdown

Violation Severity
56.7×40%
Refusal Volume
22.3×30%
Recency
0.0×20%
Frequency
30.0×10%
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.

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
9/16/2016
66YBY99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C.
75UNAPPROVED
Cincinnati District Office (CIN-DO)
8/1/2016
53LY99OTHER SKIN CARE PREPARATIONS, N.E.C.
471CSTIC LBLG
Cincinnati District Office (CIN-DO)
8/1/2016
53GY99OTHER MAKEUP PREPARATION, NOT FOR THE EYES, N.E.C.
471CSTIC LBLG
Cincinnati District Office (CIN-DO)

Frequently Asked Questions

What is Huilarome Sarl's FDA import refusal history?

Huilarome Sarl (FEI: 3011744876) has 3 FDA import refusal record(s) in our database, spanning from 8/1/2016 to 9/16/2016.

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. Huilarome Sarl's FEI number is 3011744876.

What types of violations has Huilarome Sarl received?

Huilarome Sarl has been cited for 2 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 Huilarome Sarl come from?

All FDA import refusal data for Huilarome Sarl 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.