ACHE LABORATORIOS FARMACEUTICOS
⚠️ High Risk
FEI: 3013981028 • Sao Paulo • BRAZIL
FEI Number
3013981028
Location
Sao Paulo
Country
BRAZILAddress
Brigadeiro Faria Lima 2, , Sao Paulo, , Brazil
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 |
|---|---|---|---|
| 1/21/2026 | 61NCB84DESVENLAFAXINE SUCCINATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 66NCC03QUETIAPINE FUMARATE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 66NCC02OLANZAPINE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/12/2022 | 61EAY99ANTI-ASTHMATIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/27/2021 | 56YCY99ANTIBIOTIC N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/24/2020 | 61WDA52TERBINAFINE HYDROCHLORIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/26/2020 | 66JCB01LEVOTHYROXINE SODIUM (THYROID HORMONE) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/8/2020 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is ACHE LABORATORIOS FARMACEUTICOS's FDA import refusal history?
ACHE LABORATORIOS FARMACEUTICOS (FEI: 3013981028) has 8 FDA import refusal record(s) in our database, spanning from 6/8/2020 to 1/21/2026.
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. ACHE LABORATORIOS FARMACEUTICOS's FEI number is 3013981028.
What types of violations has ACHE LABORATORIOS FARMACEUTICOS received?
ACHE LABORATORIOS FARMACEUTICOS 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 ACHE LABORATORIOS FARMACEUTICOS come from?
All FDA import refusal data for ACHE LABORATORIOS FARMACEUTICOS 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.