Roemmers S.A.
⚠️ Moderate Risk
FEI: 3005403103 • Montevideomontevideo • URUGUAY
FEI Number
3005403103
Location
Montevideomontevideo
Country
URUGUAYAddress
5364 Maldonado, , Montevideomontevideo, , Uruguay
Moderate Risk
FDA Import Risk Assessment
This firm has a moderate history of FDA import refusals. Some attention may be warranted.
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 |
|---|---|---|---|
| 11/16/2021 | 61MDY99ANTI-CONVULSANT, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/3/2020 | 60LCL17CLONIXIN (ANALGESIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2020 | 61NDA80VENLAFAXINE HYDROCHLORIDE (ANTI-DEPRESSANT) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/16/2020 | 61NCC83ESCITALOPRAM OXALATE | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Roemmers S.A.'s FDA import refusal history?
Roemmers S.A. (FEI: 3005403103) has 4 FDA import refusal record(s) in our database, spanning from 6/16/2020 to 11/16/2021.
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. Roemmers S.A.'s FEI number is 3005403103.
What types of violations has Roemmers S.A. received?
Roemmers 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 Roemmers S.A. come from?
All FDA import refusal data for Roemmers 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.