EMBELLEZE
⚠️ Moderate Risk
FEI: 3020989993 • Ipatinga, Minas Gerais • BRAZIL
FEI Number
3020989993
Location
Ipatinga, Minas Gerais
Country
BRAZILAddress
Avenida Flores, 500, , Ipatinga, Minas Gerais, 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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 801.15(c)(1)
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/14/2022 | 53LY03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | 471CSTIC LBLG | Division of Southeast Imports (DSEI) |
| 1/14/2022 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Southeast Imports (DSEI) | |
| 1/14/2022 | 80FMFSYRINGE, PISTON | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is EMBELLEZE's FDA import refusal history?
EMBELLEZE (FEI: 3020989993) has 3 FDA import refusal record(s) in our database, spanning from 1/14/2022 to 1/14/2022.
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. EMBELLEZE's FEI number is 3020989993.
What types of violations has EMBELLEZE received?
EMBELLEZE 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 EMBELLEZE come from?
All FDA import refusal data for EMBELLEZE 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.