Eurofarma Laboratorios S.A.
⚠️ High Risk
FEI: 3009538725 • Itapevi, Sao Paulo • BRAZIL
FEI Number
3009538725
Location
Itapevi, Sao Paulo
Country
BRAZILAddress
Rodovia Presidente Castelo Branco, 3565, Quadragl Lote A, Itapevi, 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).
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.
NO ENGLISH
Required label or labeling appears to not be in English in violation of 21 C.F.R. 201.15(c)(1).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/26/2025 | 61NCY78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/7/2025 | 61NCA78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2025 | 63ADY02ALENDRONATE SODIUM (BONE CALCIUM REGULATOR) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/12/2025 | 60NDY14TESTOSTERONE (ANDROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/4/2025 | 61NDY78SERTRALINE HYDROCHLORIDE (ANTI-DEPRESSANT) | Division of Southeast Imports (DSEI) | |
| 9/4/2025 | 62ODY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 8/8/2025 | 56DDA06AMIKACIN SULFATE (AMINOGLYCOSIDES) | Division of Southeast Imports (DSEI) | |
| 7/3/2025 | 60NAK06NANDROLONE DECANOATE (ANDROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/3/2025 | 60NDK19TESTOSTERONE PROPIONATE (ANDROGEN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2025 | 66NCY04RISPERIDONE (TRANQUILIZER (ANTI-PSYCHOTIC) - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2025 | 61NCY70LITHIUM (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/2/2025 | 61NCY83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/30/2025 | 61NCE37LITHIUM CARBONATE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 3/7/2025 | 61NDY83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/2/2024 | 64LDL19DEXAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 61NCF66FLUOXETINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/17/2024 | 55RY55SODIUM CHLORIDE (PHARMACEUTIC NECESSITY - TONICITY AGENT) | Division of Southeast Imports (DSEI) | |
| 5/17/2024 | 64LCY03BETAMETHASONE (GLUCOCORTICOID) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 9/22/2023 | 61LCA38CLOPIDOGREL BISULFATE (ANTI-COAGULANT) | Division of Southeast Imports (DSEI) | |
| 1/10/2023 | 62OCY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | Division of Southeast Imports (DSEI) | |
| 10/5/2020 | 56ICB76AZITHROMYCIN (MACAROLIDES) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/20/2012 | 61WBJ18MICONAZOLE NITRATE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | New Orleans District Office (NOL-DO) |
Frequently Asked Questions
What is Eurofarma Laboratorios S.A.'s FDA import refusal history?
Eurofarma Laboratorios S.A. (FEI: 3009538725) has 22 FDA import refusal record(s) in our database, spanning from 6/20/2012 to 11/26/2025.
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. Eurofarma Laboratorios S.A.'s FEI number is 3009538725.
What types of violations has Eurofarma Laboratorios S.A. received?
Eurofarma Laboratorios S.A. has been cited for 4 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 Eurofarma Laboratorios S.A. come from?
All FDA import refusal data for Eurofarma Laboratorios 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.