LABORATORIO CHILE SA
⚠️ High Risk
FEI: 3013143985 • Santiago • CHILE
FEI Number
3013143985
Location
Santiago
Country
CHILEAddress
Camino Melipilla 9978, , Santiago, , Chile
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
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 |
|---|---|---|---|
| 5/11/2023 | 60SBY23METOCLOPRAMIDE (ANTACID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/11/2023 | 62GBY90DICLOFENAC POTASSIUM (ANTI-INFLAMMATORY) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 2/2/2017 | 61NDY03AMITRIPTYLINE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 2/2/2017 | 63EDY13PROPRANOLOL HCL (CARDIAC DEPRESSANT) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is LABORATORIO CHILE SA's FDA import refusal history?
LABORATORIO CHILE SA (FEI: 3013143985) has 4 FDA import refusal record(s) in our database, spanning from 2/2/2017 to 5/11/2023.
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. LABORATORIO CHILE SA's FEI number is 3013143985.
What types of violations has LABORATORIO CHILE SA received?
LABORATORIO CHILE SA has been cited for 1 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 LABORATORIO CHILE SA come from?
All FDA import refusal data for LABORATORIO CHILE SA 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.