Distribuidora Lagunera del Norte, SA de CV
⚠️ Moderate Risk
FEI: 3017394466 • Torreon, Coahuila de Zaragoza • MEXICO
FEI Number
3017394466
Location
Torreon, Coahuila de Zaragoza
Country
MEXICOAddress
Av Juarez 5735-5, Fracc. Residencial Las Torres, 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
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).
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).
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.
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.
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).
DR QUALITC
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the drug appears to be represented as not being recognized in an official compendium and appears its strength differs from or its quality or purity falls below, that which it purports or is represented to possess.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/5/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) | |
| 1/5/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) | |
| 1/5/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) | |
| 1/5/2021 | 62HAL05ETHYL ALCOHOL (ANTI-MICROBIAL) | Division of Southwest Imports (DSWI) |
Frequently Asked Questions
What is Distribuidora Lagunera del Norte, SA de CV's FDA import refusal history?
Distribuidora Lagunera del Norte, SA de CV (FEI: 3017394466) has 4 FDA import refusal record(s) in our database, spanning from 1/5/2021 to 1/5/2021.
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. Distribuidora Lagunera del Norte, SA de CV's FEI number is 3017394466.
What types of violations has Distribuidora Lagunera del Norte, SA de CV received?
Distribuidora Lagunera del Norte, SA de CV has been cited for 7 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 Distribuidora Lagunera del Norte, SA de CV come from?
All FDA import refusal data for Distribuidora Lagunera del Norte, 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.