LABORATORIOS LIEMONT
⚠️ High Risk
FEI: 3013497614 • Cuajimalpa de Marelos • MEXICO
FEI Number
3013497614
Location
Cuajimalpa de Marelos
Country
MEXICOAddress
Adelfe Lopez Motecs #Ge, , Cuajimalpa de Marelos, , 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).
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/12/2025 | 62GCA50NAPROXEN SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 3/21/2025 | 61PDA62PIOGLITAZONE HCL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/6/2025 | 62LCY40METRONIDAZOLE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2024 | 62FCL53MOMETASONE FUROATE (ANTI-INFECTIVE, TOPICAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2024 | 61ECA09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/13/2024 | 61ECA09MONTELUKAST SODIUM (ANTI-ASTHMATIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 4/24/2024 | 61XDY14CYPROHEPTADINE HCL (ANTI-HISTAMINIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LABORATORIOS LIEMONT's FDA import refusal history?
LABORATORIOS LIEMONT (FEI: 3013497614) has 7 FDA import refusal record(s) in our database, spanning from 4/24/2024 to 12/12/2025.
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. LABORATORIOS LIEMONT's FEI number is 3013497614.
What types of violations has LABORATORIOS LIEMONT received?
LABORATORIOS LIEMONT 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 LABORATORIOS LIEMONT come from?
All FDA import refusal data for LABORATORIOS LIEMONT 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.