Industria de Nutraceuticos S.A. de C.V.
⚠️ High Risk
FEI: 3013189302 • Guadalajara, Jalisco • MEXICO
FEI Number
3013189302
Location
Guadalajara, Jalisco
Country
MEXICOAddress
Privada Benjamin Eguiluz No. 125, Col. Tetlan, Guadalajara, Guadalajara, Jalisco, Mexico
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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).
UNSAFE COL
The article appears to be, or to bear or contain a color additive which is unsafe within the meaning of Section 721(a).
DIETARYLBL
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the FD&C Act in that it is a dietary supplement that appears to be misbranded within the meaning of Section 403(s)(2)(B) of the FD&C Act in that the label or labeling fails to identify the product by using the term "dietary supplement", which term may be modified with the name of such an ingredient.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/7/2025 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 1/7/2025 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 75UNAPPROVED | Division of Southwest Imports (DSWI) |
| 12/9/2024 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2300DIETARYLBL | Division of Southwest Imports (DSWI) |
| 1/22/2020 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southwest Imports (DSWI) | |
| 1/22/2020 | 54FCH99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Division of Southwest Imports (DSWI) | |
| 1/22/2020 | 54KCH03VALERIAN (HERBAL & BOTANICALS, NOT TEAS II) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Industria de Nutraceuticos S.A. de C.V.'s FDA import refusal history?
Industria de Nutraceuticos S.A. de C.V. (FEI: 3013189302) has 6 FDA import refusal record(s) in our database, spanning from 1/22/2020 to 1/7/2025.
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. Industria de Nutraceuticos S.A. de C.V.'s FEI number is 3013189302.
What types of violations has Industria de Nutraceuticos S.A. de C.V. received?
Industria de Nutraceuticos S.A. de C.V. has been cited for 3 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 Industria de Nutraceuticos S.A. de C.V. come from?
All FDA import refusal data for Industria de Nutraceuticos 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.