NATURA-LEXA, S.A. DE C.V.
⚠️ Moderate Risk
FEI: 3004389028 • Tijuana, BC • MEXICO
FEI Number
3004389028
Location
Tijuana, BC
Country
MEXICOAddress
Calle D 5121, Fracc. Las Americas, Tijuana, BC, 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).
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
WARNINGS
It appears to lack adequate warning against use in a pathological condition or by children where it may be dangerous to health or against an unsafe dose, method, administering duration, application, in manner/form, to protect users.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
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.
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).
COLOR LBLG
The color additive appears to not have its packaging and labeling in conformity with such requirements as issued under section 721.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/8/2010 | 62MBJ01CAMPHOR (ANTI-PRURITIC) | Southwest Import District Office (SWI-DO) | |
| 4/7/2009 | 53YC99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 8/23/2005 | 53YY99OTHER COSMETIC AND COSMETIC PRODUCTS, N.E.C. | 198COLOR LBLG | Southwest Import District Office (SWI-DO) |
| 6/2/2005 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 6/2/2005 | 53LD06MOISTURIZING (SKIN CARE PREPARATIONS) | 197COSM COLOR | Southwest Import District Office (SWI-DO) |
| 11/6/2003 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | Southwest Import District Office (SWI-DO) | |
| 8/15/2003 | 66VBJ99MISCELLANEOUS PATENT MEDICINES, ETC. | 473LABELING | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is NATURA-LEXA, S.A. DE C.V.'s FDA import refusal history?
NATURA-LEXA, S.A. DE C.V. (FEI: 3004389028) has 7 FDA import refusal record(s) in our database, spanning from 8/15/2003 to 11/8/2010.
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.A. DE C.V.'s FEI number is 3004389028.
What types of violations has NATURA-LEXA, S.A. DE C.V. received?
NATURA-LEXA, S.A. DE C.V. has been cited for 9 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, S.A. DE C.V. come from?
All FDA import refusal data for NATURA-LEXA, S.A. DE C.V. 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.