MERCK & SHARP & DOHME COLOMBIA
⚠️ Moderate Risk
FEI: 3014203869 • Bogota • COLOMBIA
FEI Number
3014203869
Location
Bogota
Country
COLOMBIAAddress
Calle 127 A No 53 A 45, , 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
708NOREG
It has been determined the drug was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
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 MERCK & SHARP & DOHME COLOMBIA's FDA import refusal history?
MERCK & SHARP & DOHME COLOMBIA (FEI: 3014203869) has 2 FDA import refusal record(s) in our database, spanning from 9/4/2020 to 12/4/2020.
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. MERCK & SHARP & DOHME COLOMBIA's FEI number is 3014203869.
What types of violations has MERCK & SHARP & DOHME COLOMBIA received?
MERCK & SHARP & DOHME COLOMBIA 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 MERCK & SHARP & DOHME COLOMBIA come from?
All FDA import refusal data for MERCK & SHARP & DOHME COLOMBIA 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.