INSTITUTO PARA NINO CIEGOS Y
⚠️ High Risk
FEI: 3031996945 • Valle Del Cauca • COLOMBIA
FEI Number
3031996945
Location
Valle Del Cauca
Country
COLOMBIAAddress
Carrera 38# 5b1-39, , Valle Del Cauca, , 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
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 |
|---|---|---|---|
| 10/7/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/7/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/7/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) | |
| 10/7/2024 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is INSTITUTO PARA NINO CIEGOS Y's FDA import refusal history?
INSTITUTO PARA NINO CIEGOS Y (FEI: 3031996945) has 4 FDA import refusal record(s) in our database, spanning from 10/7/2024 to 10/7/2024.
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. INSTITUTO PARA NINO CIEGOS Y's FEI number is 3031996945.
What types of violations has INSTITUTO PARA NINO CIEGOS Y received?
INSTITUTO PARA NINO CIEGOS Y 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 INSTITUTO PARA NINO CIEGOS Y come from?
All FDA import refusal data for INSTITUTO PARA NINO CIEGOS Y 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.