Natura-Lexa
⚠️ Moderate Risk
FEI: 3008855472 • Tijuana, Baja California • MEXICO
FEI Number
3008855472
Location
Tijuana, Baja California
Country
MEXICOAddress
Calle Rio Suchiate # 9447, Col. MARRON, Tijuana, Baja California, Mexico
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
COSM COLOR
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to contain a color additive which is unsafe within the meaning of Section 721(a) which renders it adulterated under Section 601(e).
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.
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/17/2013 | 53CG06MASCARA (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 10/2/2012 | 53LC03FACE,BODY,AND HAND (EXCLUDING SHAVING PREPARATIONS) (SKIN CARE PREPARATIONS) | Southwest Import District Office (SWI-DO) | |
| 1/10/2012 | 53CY06MASCARA (EYE MAKEUP PREPARATIONS) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 12/22/2011 | 66PBJ04DIOXYBENZONE (ULTRAVIOLET SCREEN/SUNSCREEN) | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Natura-Lexa's FDA import refusal history?
Natura-Lexa (FEI: 3008855472) has 4 FDA import refusal record(s) in our database, spanning from 12/22/2011 to 9/17/2013.
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-Lexa's FEI number is 3008855472.
What types of violations has Natura-Lexa received?
Natura-Lexa 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 Natura-Lexa come from?
All FDA import refusal data for Natura-Lexa 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.