LABORATORIOS SYNTHESIS S A S
⚠️ Moderate Risk
FEI: 3012698189 • Bogota, Cundinamarca • COLOMBIA
FEI Number
3012698189
Location
Bogota, Cundinamarca
Country
COLOMBIAAddress
Carrera 44 20c 73, C, Bogota, 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
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 LABORATORIOS SYNTHESIS S A S's FDA import refusal history?
LABORATORIOS SYNTHESIS S A S (FEI: 3012698189) has 2 FDA import refusal record(s) in our database, spanning from 7/29/2020 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. LABORATORIOS SYNTHESIS S A S's FEI number is 3012698189.
What types of violations has LABORATORIOS SYNTHESIS S A S received?
LABORATORIOS SYNTHESIS 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 LABORATORIOS SYNTHESIS S A S come from?
All FDA import refusal data for LABORATORIOS SYNTHESIS 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.