Cosmed Industria de Cosmeticos e Medicamentos S/A
⚠️ Moderate Risk
FEI: 3010343023 • Sao Paulo, Sao Paulo • BRAZIL
FEI Number
3010343023
Location
Sao Paulo, Sao Paulo
Country
BRAZILAddress
Avenida Ceci, 282, , 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
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
Frequently Asked Questions
What is Cosmed Industria de Cosmeticos e Medicamentos S/A's FDA import refusal history?
Cosmed Industria de Cosmeticos e Medicamentos S/A (FEI: 3010343023) has 2 FDA import refusal record(s) in our database, spanning from 9/17/2013 to 2/26/2016.
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. Cosmed Industria de Cosmeticos e Medicamentos S/A's FEI number is 3010343023.
What types of violations has Cosmed Industria de Cosmeticos e Medicamentos S/A received?
Cosmed Industria de Cosmeticos e Medicamentos S/A has been cited for 5 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 Cosmed Industria de Cosmeticos e Medicamentos S/A come from?
All FDA import refusal data for Cosmed Industria de Cosmeticos e Medicamentos S/A 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.