Potosi 20 S.A.S.
⚠️ Moderate Risk
FEI: 3009865850 • Bogota • COLOMBIA
FEI Number
3009865850
Location
Bogota
Country
COLOMBIAAddress
Carrera 7 No.60-92, , Bogota, , 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
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).
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 |
|---|---|---|---|
| 6/11/2015 | 65L99PROTECTANT N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 6/11/2015 | 65L99PROTECTANT N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 6/11/2015 | 65L99PROTECTANT N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 6/11/2015 | 65L99PROTECTANT N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 6/11/2015 | 65L99PROTECTANT N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 6/11/2015 | 65L99PROTECTANT N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 6/11/2015 | 65L99PROTECTANT N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 6/11/2015 | 65L99PROTECTANT N.E.C. | 118NOT LISTED | Division of Northeast Imports (DNEI) |
| 12/17/2013 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/23/2013 | 53LD09SKIN FRESHENERS (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Potosi 20 S.A.S.'s FDA import refusal history?
Potosi 20 S.A.S. (FEI: 3009865850) has 10 FDA import refusal record(s) in our database, spanning from 10/23/2013 to 6/11/2015.
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. Potosi 20 S.A.S.'s FEI number is 3009865850.
What types of violations has Potosi 20 S.A.S. received?
Potosi 20 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 Potosi 20 S.A.S. come from?
All FDA import refusal data for Potosi 20 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.