Ems S.A.
⚠️ High Risk
FEI: 3010909284 • Hortolandia, Sao Paulo • BRAZIL
FEI Number
3010909284
Location
Hortolandia, Sao Paulo
Country
BRAZILAddress
Rodovia Jornalista Francisco Aguirre, Proenca, Hortolandia, 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).
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 |
|---|---|---|---|
| 10/22/2025 | 62VCY25FAMCICLOVIR (ANTI-VIRAL) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 11/20/2024 | 61WDL23POTASSIUM IODIDE (ANTI-FUNGAL) (NOT ANTIBIOTIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/24/2024 | 64UDA99INHIBITOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/24/2024 | 63VDA99DEPIGMENTOR N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/16/2024 | 61LCC42RIVAROXABAN | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/12/2022 | 64LCB56PREDNISONE (GLUCOCORTICOID) | Division of Southeast Imports (DSEI) | |
| 9/12/2022 | 64BCY14CHLORTHALIDONE (DIURETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/14/2022 | 62ODY41LOSARTAN POTASSIUM (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 10/5/2017 | 60LBY99ANALGESIC, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Ems S.A.'s FDA import refusal history?
Ems S.A. (FEI: 3010909284) has 9 FDA import refusal record(s) in our database, spanning from 10/5/2017 to 10/22/2025.
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. Ems S.A.'s FEI number is 3010909284.
What types of violations has Ems S.A. received?
Ems 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 Ems S.A. come from?
All FDA import refusal data for Ems 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.