NATURA COSMETICOS SA
⚠️ Moderate Risk
FEI: 3012586357 • Sao Paulo, Sao Paulo • BRAZIL
FEI Number
3012586357
Location
Sao Paulo, Sao Paulo
Country
BRAZILAddress
Avenida Alexandre Colares 1188, , 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).
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).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
LBLG ADVER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/8/2017 | 62WDY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | 2020LBLG ADVER | Division of Southeast Imports (DSEI) |
| 12/8/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 12/8/2017 | 62WDY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Division of Southeast Imports (DSEI) | |
| 12/8/2017 | 62WDY02ALDIOXA (ASTRINGENT/ANTI-PERSPIRANT) | Division of Southeast Imports (DSEI) | |
| 12/8/2017 | 62WDY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Division of Southeast Imports (DSEI) | |
| 12/8/2017 | 62WDY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Division of Southeast Imports (DSEI) | |
| 12/8/2017 | 62WDY17ALUMINUM CHLORIDE ASTRINGENT/ANTI-PERSPIRANT) | Division of Southeast Imports (DSEI) | |
| 12/8/2017 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is NATURA COSMETICOS SA's FDA import refusal history?
NATURA COSMETICOS SA (FEI: 3012586357) has 8 FDA import refusal record(s) in our database, spanning from 12/8/2017 to 12/8/2017.
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. NATURA COSMETICOS SA's FEI number is 3012586357.
What types of violations has NATURA COSMETICOS SA received?
NATURA COSMETICOS SA has been cited for 4 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 NATURA COSMETICOS SA come from?
All FDA import refusal data for NATURA COSMETICOS SA 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.