Nartex Laboratorios Homeopaticos S.A. de C.V.
⚠️ Moderate Risk
FEI: 3009407408 • Torreon, Coahuila de Zaragoza • MEXICO
FEI Number
3009407408
Location
Torreon, Coahuila de Zaragoza
Country
MEXICOAddress
Privada Lazaro Cardenas 770, Col. Eduardo Guerra, Torreon, Torreon, Coahuila de Zaragoza, 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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
COL ADDED
The article appears to bear or contain, for the purpose of coloring only, a color additive which is unsafe within the meaning of Section 721(a).
N-RX INACT
The article appears to be a nonprescription drug and fails to bear the established name of each inactive ingredient in alphabetical order on the outside container of the retail package.
UNSAFE COL
The article appears to be a color additive for the purposes of coloring only in or on drugs or devices, and is unsafe within the meaning of Section 721(a).
NEEDS FCE
It appears the manufacturer is not registered as a low acid canned food or acidified food manufacturer pursuant to 21 CFR 108.25(c)(1) or 108.35(c)(1).
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).
NO PROCESS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the manufacturer's failure to file a scheduled process demonstrates that the product is not being manufactured under the mandatory provisions of 21 CFR Part 108 and therefore appears to have been manufactured, processed, or packed, under insanitary conditions whereby it may have been rendered injurious to health.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/5/2022 | 62GBJ99ANTI-INFLAMMATORY N.E.C. | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 4/8/2020 | 41YHI99DIETARY CONVENTIONAL FOODS, N.E.C. | Division of Southwest Imports (DSWI) | |
| 5/22/2012 | 62GBY99ANTI-INFLAMMATORY N.E.C. | Southwest Import District Office (SWI-DO) | |
| 4/30/2012 | 66BBY99STIMULANT N.E.C. | Southwest Import District Office (SWI-DO) | |
| 4/10/2012 | 60RBY99ANOREXIC, N.E.C. | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is Nartex Laboratorios Homeopaticos S.A. de C.V.'s FDA import refusal history?
Nartex Laboratorios Homeopaticos S.A. de C.V. (FEI: 3009407408) has 5 FDA import refusal record(s) in our database, spanning from 4/10/2012 to 10/5/2022.
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. Nartex Laboratorios Homeopaticos S.A. de C.V.'s FEI number is 3009407408.
What types of violations has Nartex Laboratorios Homeopaticos S.A. de C.V. received?
Nartex Laboratorios Homeopaticos S.A. de C.V. has been cited for 8 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 Nartex Laboratorios Homeopaticos S.A. de C.V. come from?
All FDA import refusal data for Nartex Laboratorios Homeopaticos 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.