Prof.Nr Cosmeticos Naturais Ltda Ep
⚠️ Moderate Risk
FEI: 3005857036 • Sao Paulo, Sao Paulo • BRAZIL
FEI Number
3005857036
Location
Sao Paulo, Sao Paulo
Country
BRAZILAddress
Rua Manoel Soares Sebastiao, , Sao Paulo, Sao Paulo, Brazil
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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
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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/14/2012 | 53LC99OTHER SKIN CARE PREPARATIONS, N.E.C. | 475COSMETLBLG | New Orleans District Office (NOL-DO) |
| 12/14/2012 | 65LBY99PROTECTANT N.E.C. | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 6/20/2012 | 30JYT99IMITATION FRUIT FLAVORED BEVERAGE BASE, N.E.C. | 11UNSAFE COL | New Orleans District Office (NOL-DO) |
| 3/6/2009 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 3/6/2009 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
| 3/6/2009 | 66PBJ99ULTRAVIOLET SCREEN/SUNSCREEN N.E.C. | 118NOT LISTED | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is Prof.Nr Cosmeticos Naturais Ltda Ep's FDA import refusal history?
Prof.Nr Cosmeticos Naturais Ltda Ep (FEI: 3005857036) has 6 FDA import refusal record(s) in our database, spanning from 3/6/2009 to 12/14/2012.
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. Prof.Nr Cosmeticos Naturais Ltda Ep's FEI number is 3005857036.
What types of violations has Prof.Nr Cosmeticos Naturais Ltda Ep received?
Prof.Nr Cosmeticos Naturais Ltda Ep has been cited for 3 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 Prof.Nr Cosmeticos Naturais Ltda Ep come from?
All FDA import refusal data for Prof.Nr Cosmeticos Naturais Ltda Ep 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.