TWO WAY SOLUTIONS C.I. S.A.S.
⚠️ Moderate Risk
FEI: 3015842175 • Antioquia • COLOMBIA
FEI Number
3015842175
Location
Antioquia
Country
COLOMBIAAddress
Carrera 63 # 59-160 Bodegas Del Norte, Int. 19, , Antioquia, , Colombia
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
DIRSEXMPT
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a drug within the meaning of Section 201(g) and it lacks adequate directions for use.
CSTIC LBLG
The labeling appears to fail to comply with cosmetic labeling requirements of Section 602(a), and/or (b), and/or (c), and as identified by 21 C.F.R. Part 701.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/8/2025 | 53LH99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/8/2025 | 53LH99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/8/2025 | 53LH99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/8/2025 | 53LH99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/8/2025 | 53LH99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) | |
| 1/8/2025 | 53LH99OTHER SKIN CARE PREPARATIONS, N.E.C. | Division of Northeast Imports (DNEI) |
Frequently Asked Questions
What is TWO WAY SOLUTIONS C.I. S.A.S.'s FDA import refusal history?
TWO WAY SOLUTIONS C.I. S.A.S. (FEI: 3015842175) has 6 FDA import refusal record(s) in our database, spanning from 1/8/2025 to 1/8/2025.
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. TWO WAY SOLUTIONS C.I. S.A.S.'s FEI number is 3015842175.
What types of violations has TWO WAY SOLUTIONS C.I. S.A.S. received?
TWO WAY SOLUTIONS C.I. S.A.S. has been cited for 2 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 TWO WAY SOLUTIONS C.I. S.A.S. come from?
All FDA import refusal data for TWO WAY SOLUTIONS C.I. S.A.S. 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.