Osce Shiller

⚠️ Moderate Risk

FEI: 3004374605 • Port-Au-Prince, ouest • HAITI

FEI

FEI Number

3004374605

📍

Location

Port-Au-Prince, ouest

🇭🇹

Country

HAITI

🏢

Address

Rue Alexandre # 4, , Port-Au-Prince, ouest, Haiti

Moderate Risk

FDA Import Risk Assessment

36.1

LowModerateHighCritical

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

Statistics

Total Refusals

Unique Violations

7/7/2004

Latest Refusal

5/25/2004

Earliest Refusal

Score Breakdown

Violation Severity

40.0×40%

Refusal Volume

37.0×30%

Recency

0.0×20%

Frequency

90.0×10%

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

Violation Summary

4719×

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.

4739×

LABELING

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

Refusal History

Date	Product	Violations	Division
7/7/2004	53JH99OTHER PERSONAL CLEANLINESS PRODUCTS (NOT ANTIPERSPIRANT), N.E.C.	471CSTIC LBLG 473LABELING	Florida District Office (FLA-DO)
7/7/2004	53LC06MOISTURIZING (SKIN CARE PREPARATIONS)	471CSTIC LBLG 473LABELING	Florida District Office (FLA-DO)
5/25/2004	53EG03HAIR STRAIGHTENERS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING	Florida District Office (FLA-DO)
5/25/2004	53DD01COLOGNES AND TOILET WATERS (FRAGRANCE PREPARATIONS)	471CSTIC LBLG 473LABELING	Florida District Office (FLA-DO)
5/25/2004	53LG99OTHER SKIN CARE PREPARATIONS, N.E.C.	471CSTIC LBLG 473LABELING	Florida District Office (FLA-DO)
5/25/2004	53JD03DOUCHES (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING	Florida District Office (FLA-DO)
5/25/2004	53JD03DOUCHES (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING	Florida District Office (FLA-DO)
5/25/2004	53JD03DOUCHES (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS)	471CSTIC LBLG 473LABELING	Florida District Office (FLA-DO)
5/25/2004	53ED07TONICS, DRESSINGS, AND OTHER HAIR GROOMING AIDS (HAIR PREPARATIONS, NON-COLORING)	471CSTIC LBLG 473LABELING	Florida District Office (FLA-DO)

Frequently Asked Questions

What is Osce Shiller's FDA import refusal history?

Osce Shiller (FEI: 3004374605) has 9 FDA import refusal record(s) in our database, spanning from 5/25/2004 to 7/7/2004.

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. Osce Shiller's FEI number is 3004374605.

What types of violations has Osce Shiller received?

Osce Shiller 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 Osce Shiller come from?

All FDA import refusal data for Osce Shiller 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.