Yanbal de Colombia, S.A.
⚠️ Moderate Risk
FEI: 3005782872 • Facatativa, Cundinamarca • COLOMBIA
FEI Number
3005782872
Location
Facatativa, Cundinamarca
Country
COLOMBIAAddress
Calle 15 5 187, , Facatativa, Cundinamarca, 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
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
DRUG NAME
The article appears to be a drug and fails to bear the proprietary or established name and/or name and quantity of each active ingredient.
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
Frequently Asked Questions
What is Yanbal de Colombia, S.A.'s FDA import refusal history?
Yanbal de Colombia, S.A. (FEI: 3005782872) has 1 FDA import refusal record(s) in our database, spanning from 10/30/2006 to 10/30/2006.
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. Yanbal de Colombia, S.A.'s FEI number is 3005782872.
What types of violations has Yanbal de Colombia, S.A. received?
Yanbal de Colombia, S.A. has been cited for 4 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 Yanbal de Colombia, S.A. come from?
All FDA import refusal data for Yanbal de Colombia, S.A. 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.