COSMED GROUP OF DR
⚠️ Moderate Risk
FEI: 3022413126 • La Caleta • DOMINICAN REPUBLIC
FEI Number
3022413126
Location
La Caleta
Country
DOMINICAN REPUBLICAddress
Las America Industrialfree Zone Kilometro 22 Auto, , La Caleta, , Dominican Republic
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
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/9/2022 | 74DQECATHETER, OXIMETER, FIBEROPTIC | Division of Southeast Imports (DSEI) | |
| 11/9/2022 | 74DQECATHETER, OXIMETER, FIBEROPTIC | Division of Southeast Imports (DSEI) | |
| 11/9/2022 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) | |
| 11/9/2022 | 74DXOTRANSDUCER, PRESSURE, CATHETER TIP | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is COSMED GROUP OF DR's FDA import refusal history?
COSMED GROUP OF DR (FEI: 3022413126) has 4 FDA import refusal record(s) in our database, spanning from 11/9/2022 to 11/9/2022.
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. COSMED GROUP OF DR's FEI number is 3022413126.
What types of violations has COSMED GROUP OF DR received?
COSMED GROUP OF DR 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 COSMED GROUP OF DR come from?
All FDA import refusal data for COSMED GROUP OF DR 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.