Green ELV Nutrition, SA de CV
⚠️ Moderate Risk
FEI: 3014366841 • Apodaca, Nuevo Leon • MEXICO
FEI Number
3014366841
Location
Apodaca, Nuevo Leon
Country
MEXICOAddress
Carretera Laredo Km. 16.5 Col. Moises Saenz, Bodega 6, , Apodaca, Nuevo Leon, 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
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).
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).
FILTHY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to consist in whole or in part of a filthy, putrid, or decomposed substance or be otherwise unfit for food.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/31/2023 | 54YYR99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 249FILTHY | Division of Southwest Imports (DSWI) |
| 4/21/2021 | 62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 4/21/2021 | 62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 4/21/2021 | 62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL) | 27DRUG GMPS | Division of Southwest Imports (DSWI) |
| 6/1/2020 | 62HBY05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Green ELV Nutrition, SA de CV's FDA import refusal history?
Green ELV Nutrition, SA de CV (FEI: 3014366841) has 5 FDA import refusal record(s) in our database, spanning from 6/1/2020 to 8/31/2023.
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. Green ELV Nutrition, SA de CV's FEI number is 3014366841.
What types of violations has Green ELV Nutrition, SA de CV received?
Green ELV Nutrition, SA de CV 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 Green ELV Nutrition, SA de CV come from?
All FDA import refusal data for Green ELV Nutrition, SA de CV 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.