New Stetic
⚠️ Moderate Risk
FEI: 3003794907 • Antioquia • COLOMBIA
FEI Number
3003794907
Location
Antioquia
Country
COLOMBIAAddress
Carrera 53, No. 50-09, , Guarne, Antioquia, , Colombia
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.
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
REGISTERED
It appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5).
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 |
|---|---|---|---|
| 3/13/2024 | 76ELWMATERIAL, IMPRESSION | Division of Southeast Imports (DSEI) | |
| 3/13/2024 | 76DYNMOUTHPIECE, SALIVA EJECTOR | Division of Southeast Imports (DSEI) | |
| 3/13/2024 | 60QCK41MEPIVACAINE HCL (ANESTHETIC) | Division of Southeast Imports (DSEI) | |
| 3/13/2024 | 60QDK40LIDOCAINE HCL (ANESTHETIC) | Division of Southeast Imports (DSEI) | |
| 7/26/2021 | 76DZNMATRIX, DENTAL | Division of Southeast Imports (DSEI) | |
| 7/26/2021 | 76EBIRESIN, DENTURE, RELINING, REPAIRING, REBASING | Division of Southeast Imports (DSEI) | |
| 7/26/2021 | 76EFWTOOTHBRUSH, MANUAL | Division of Southeast Imports (DSEI) | |
| 7/20/2020 | 60QAY67LIDOCAINE (ANESTHETIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 1/21/2020 | 76ELWMATERIAL, IMPRESSION | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/26/2018 | 60CBY04EPINEPHRINE (ADRENERGIC) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/19/2004 | 76KLEAGENT, TOOTH BONDING, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 7/19/2004 | 76KLEAGENT, TOOTH BONDING, RESIN | 341REGISTERED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is New Stetic's FDA import refusal history?
New Stetic (FEI: 3003794907) has 12 FDA import refusal record(s) in our database, spanning from 7/19/2004 to 3/13/2024.
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. New Stetic's FEI number is 3003794907.
What types of violations has New Stetic received?
New Stetic has been cited for 5 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 New Stetic come from?
All FDA import refusal data for New Stetic 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.