Farmoquimica S.A.
⚠️ High Risk
FEI: 3008259437 • Rio De Janeiro, Rio de Janeiro • BRAZIL
FEI Number
3008259437
Location
Rio De Janeiro, Rio de Janeiro
Country
BRAZILAddress
Rua Viuva Claudio, 300, , Rio De Janeiro, Rio de Janeiro, 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 |
|---|---|---|---|
| 12/5/2025 | 65JDA31PROGESTERONE (PROGESTIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/26/2025 | 61WDY54TICONAZOLE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/24/2024 | 62KDA11NITAZOXANIDE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 5/10/2023 | 61LDY12WARFARIN POTASSIUM (ANTI-COAGULANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Farmoquimica S.A.'s FDA import refusal history?
Farmoquimica S.A. (FEI: 3008259437) has 4 FDA import refusal record(s) in our database, spanning from 5/10/2023 to 12/5/2025.
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. Farmoquimica S.A.'s FEI number is 3008259437.
What types of violations has Farmoquimica S.A. received?
Farmoquimica S.A. 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 Farmoquimica S.A. come from?
All FDA import refusal data for Farmoquimica 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.