Aspen Farmaceutica S/A
⚠️ High Risk
FEI: 3018945355 • Sao Paulo • BRAZIL
FEI Number
3018945355
Location
Sao Paulo
Country
BRAZILAddress
Rua La Paz, 37/67, Santo Amaro, 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/21/2026 | 61NCA60TRAZODONE HCL (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/4/2025 | 61NDY60TRAZODONE HCL (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 6/22/2021 | 62LDA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/22/2021 | 62LDA29HYDROXYCHLOROQUINE SULFATE (ANTI-PROTOZOAL, A-LEISHMANIAL, A-MALARIAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Aspen Farmaceutica S/A's FDA import refusal history?
Aspen Farmaceutica S/A (FEI: 3018945355) has 4 FDA import refusal record(s) in our database, spanning from 6/22/2021 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. Aspen Farmaceutica S/A's FEI number is 3018945355.
What types of violations has Aspen Farmaceutica S/A received?
Aspen Farmaceutica S/A 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 Aspen Farmaceutica S/A come from?
All FDA import refusal data for Aspen Farmaceutica 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.