LABORATORIOS SILANES SA DE CV
⚠️ High Risk
FEI: 3015238179 • Toluca • MEXICO
FEI Number
3015238179
Location
Toluca
Country
MEXICOAddress
Eje 3 Nte No 200 Esq, , Toluca, , 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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/24/2025 | 62GCY42INDOMETHACIN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/13/2025 | 62UDE01BENZONATATE (ANTI-TUSSIVE/COLD) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/31/2025 | 62GCY99ANTI-INFLAMMATORY N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2025 | 62BCY99ANTI-HYPERLIPIDEMIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/5/2025 | 62YDA07MELOXICAM (ANTI-INFLAMMATORY, PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/28/2025 | 54AGY02VITAMIN B1 (THIAMINE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/22/2024 | 54AGA12FOLIC ACID (VITAMIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/29/2023 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/5/2022 | 62GBA42INDOMETHACIN (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2021 | 65QAY99RELAXANT N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 12/16/2021 | 61PCY26METFORMIN (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2020 | 61PDA55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/6/2020 | 61PDA55METFORMIN HCL (ANTI-DIABETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is LABORATORIOS SILANES SA DE CV's FDA import refusal history?
LABORATORIOS SILANES SA DE CV (FEI: 3015238179) has 13 FDA import refusal record(s) in our database, spanning from 11/6/2020 to 9/24/2025.
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 SILANES SA DE CV's FEI number is 3015238179.
What types of violations has LABORATORIOS SILANES SA DE CV received?
LABORATORIOS SILANES SA DE CV has been cited for 1 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 SILANES SA DE CV come from?
All FDA import refusal data for LABORATORIOS SILANES 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.