INSTITUTO HOMEM
⚠️ High Risk
FEI: 3038228576 • Sao Paulo • BRAZIL
FEI Number
3038228576
Location
Sao Paulo
Country
BRAZILAddress
Avenida Brigadeiro 13, , 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 |
|---|---|---|---|
| 6/16/2025 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2025 | 54YGY99VITAMIN, MINERAL, PROTEINS AND UNCONVENTIONAL DIETARY SPECIALITIES FOR HUMANS AND ANIMALS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2025 | 60XDY03PHENTOLAMINE HCL (ANTI-ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2025 | 54CGY20L-TRYPTOPHAN (PROTEIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2025 | 66SDY51TADALAFIL | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2025 | 54KGY20MACA (HERBAL & BOTANICALS, NOT TEAS II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2025 | 54CGY02L-ARGININE (PROTEIN) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2025 | 54FGY89TRIBULUS (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2025 | 54FGY89TRIBULUS (HERBAL & BOTANICALS, NOT TEAS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is INSTITUTO HOMEM's FDA import refusal history?
INSTITUTO HOMEM (FEI: 3038228576) has 9 FDA import refusal record(s) in our database, spanning from 6/16/2025 to 6/16/2025.
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. INSTITUTO HOMEM's FEI number is 3038228576.
What types of violations has INSTITUTO HOMEM received?
INSTITUTO HOMEM 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 INSTITUTO HOMEM come from?
All FDA import refusal data for INSTITUTO HOMEM 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.