NATURELLE INDUSTRIA E COMERCIO DE PRODUTOS NATURAIS LTDA
⚠️ Moderate Risk
FEI: 3024227207 • Cotia, Sao Paulo • BRAZIL
FEI Number
3024227207
Location
Cotia, Sao Paulo
Country
BRAZILAddress
Rua Howard Archibaldi Acheson Junior, 623, , Cotia, 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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/3/2016 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 3/3/2016 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) | |
| 3/3/2016 | 66VAY99MISCELLANEOUS PATENT MEDICINES, ETC. | Cincinnati District Office (CIN-DO) |
Frequently Asked Questions
What is NATURELLE INDUSTRIA E COMERCIO DE PRODUTOS NATURAIS LTDA's FDA import refusal history?
NATURELLE INDUSTRIA E COMERCIO DE PRODUTOS NATURAIS LTDA (FEI: 3024227207) has 3 FDA import refusal record(s) in our database, spanning from 3/3/2016 to 3/3/2016.
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. NATURELLE INDUSTRIA E COMERCIO DE PRODUTOS NATURAIS LTDA's FEI number is 3024227207.
What types of violations has NATURELLE INDUSTRIA E COMERCIO DE PRODUTOS NATURAIS LTDA received?
NATURELLE INDUSTRIA E COMERCIO DE PRODUTOS NATURAIS LTDA 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 NATURELLE INDUSTRIA E COMERCIO DE PRODUTOS NATURAIS LTDA come from?
All FDA import refusal data for NATURELLE INDUSTRIA E COMERCIO DE PRODUTOS NATURAIS LTDA 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.