Kirey Comercio De Cosmeticos
⚠️ High Risk
FEI: 3004603881 • Curitiba, Parana • BRAZIL
FEI Number
3004603881
Location
Curitiba, Parana
Country
BRAZILAddress
Rua Paul Garfunkel 455, , Curitiba, Parana, Brazil
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
Statistics
Score Breakdown
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
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).
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/5/2005 | 30GGE99BEVERAGE BASE OF NON-FRUIT ORIGIN, LIQUID, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/29/2005 | 60LBL99ANALGESIC, N.E.C. | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/19/2004 | 53BD01BATH OILS, TABLETS AND SALTS (BATH PREPARATIONS) | 75UNAPPROVED | Southwest Import District Office (SWI-DO) |
| 8/19/2004 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 8/19/2004 | 53EC06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 8/19/2004 | 53EC06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 8/19/2004 | 53EC06SHAMPOOS (HAIR PREPARATIONS, NON-COLORING) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 8/19/2004 | 53ED01HAIR CONDITIONERS (HAIR PREPARATIONS, NON-COLORING) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 8/19/2004 | 53JD01BATH SOAPS AND DETERGENTS (NOT ANTIPERSPIRANT) (PERSONAL CLEANLINESS) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
| 8/19/2004 | 53AC02LOTIONS, OILS, POWDERS AND CREAMS (BABY PRODUCTS) | 11UNSAFE COL | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Kirey Comercio De Cosmeticos's FDA import refusal history?
Kirey Comercio De Cosmeticos (FEI: 3004603881) has 10 FDA import refusal record(s) in our database, spanning from 8/19/2004 to 12/5/2005.
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. Kirey Comercio De Cosmeticos's FEI number is 3004603881.
What types of violations has Kirey Comercio De Cosmeticos received?
Kirey Comercio De Cosmeticos 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 Kirey Comercio De Cosmeticos come from?
All FDA import refusal data for Kirey Comercio De Cosmeticos 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.