Laboratorio Chile S.A.
⚠️ High Risk
FEI: 3002138892 • 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).
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).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. It appears that it was manufactured, prepared, propagated, compounded, or processed in an establishment not duly registered under section 510 of the Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/2/2025 | 62GBR18DICLOFENAC SODIUM (ANTI-INFLAMMATORY) | Division of Southeast Imports (DSEI) | |
| 2/27/2024 | 56ICY76AZITHROMYCIN (MACAROLIDES) | Division of Southeast Imports (DSEI) | |
| 3/12/2010 | 61JCY08ATORVASTATIN CALCIUM (ANTI-CHOLESTEREMIC) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/12/2010 | 62OCY28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 3/7/2007 | 65JDA16GESTONORONE CAPROATE (PROGESTIN) | 75UNAPPROVED | Cincinnati District Office (CIN-DO) |
| 9/8/2005 | 62OCA28ENALAPRIL MALEATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/8/2005 | 64BDC25HYDROCHLOROTHIAZIDE (DIURETIC) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
| 9/8/2005 | 66MCA03ALPRAZOLAM (TRANQUILIZER) | 75UNAPPROVED | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Laboratorio Chile S.A.'s FDA import refusal history?
Laboratorio Chile S.A. (FEI: 3002138892) has 8 FDA import refusal record(s) in our database, spanning from 9/8/2005 to 1/2/2025.
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 S.A.'s FEI number is 3002138892.
What types of violations has Laboratorio Chile S.A. received?
Laboratorio Chile S.A. has been cited for 3 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 S.A. come from?
All FDA import refusal data for Laboratorio Chile 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.