Legrand Sa
⚠️ High Risk
FEI: 3005243237 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3005243237
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Calle 2 1 No 68b-50, , Bogota, Cundinamarca, Colombia
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).
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
RX DEVICE
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a prescription device that appears to not feature a prescription device legend as required by 21 CFR 801.109.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/25/2025 | 61JDA16ROSUVASTATIN CALCIUM | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/21/2006 | 80FMFSYRINGE, PISTON | 84RX DEVICE | New Orleans District Office (NOL-DO) |
| 7/20/2006 | 62UDA13HYDROCODONE BITARTRATE (ANTI-TUSSIVE/COLD) | 472NO ENGLISH | New Orleans District Office (NOL-DO) |
| 7/20/2006 | 66VCA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Legrand Sa's FDA import refusal history?
Legrand Sa (FEI: 3005243237) has 4 FDA import refusal record(s) in our database, spanning from 7/20/2006 to 11/25/2025.
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. Legrand Sa's FEI number is 3005243237.
What types of violations has Legrand Sa received?
Legrand Sa 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 Legrand Sa come from?
All FDA import refusal data for Legrand Sa 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.