Sometech Incorporated
⚠️ Moderate Risk
FEI: 3002992007 • Seoul • SOUTH KOREA
FEI Number
3002992007
Location
Seoul
Country
SOUTH KOREAAddress
2f, Byuksan Digital Valley Iii, 212-13, Gurodong, Guro-Ku, Seoul, , South Korea
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.
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).
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
FRNMFGREG
The article is subject to refusal of admission pursuant to section 801(o) in that it is being imported or offered for import into the United States, and the importer, owner, or consignee of such article did not, at the time of offering the article for import, submit to the Secretary a statement that identifies the registration under section 510(i) of the Act of each establishment that with respect to such article is required under such section to register with the Secretary.
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
STD LABEL
The article appears to not bear labeling prescribed by the performance standard established under section 514.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/15/2016 | 78FEMACCESSORIES, PHOTOGRAPHIC, FOR ENDOSCOPE (EXCLUDE LIGHT SOURCES) | Seattle District Office (SEA-DO) | |
| 6/4/2013 | 79OAPLASER, COMB, HAIR | Seattle District Office (SEA-DO) | |
| 12/27/2011 | 85HEXCOLPOSCOPE (AND COLPOMICROSCOPE) | 290DE IMP GMP | Atlanta District Office (ATL-DO) |
| 8/15/2008 | 79GEIDEVICE, ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES | 341REGISTERED | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Sometech Incorporated's FDA import refusal history?
Sometech Incorporated (FEI: 3002992007) has 4 FDA import refusal record(s) in our database, spanning from 8/15/2008 to 6/15/2016.
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. Sometech Incorporated's FEI number is 3002992007.
What types of violations has Sometech Incorporated received?
Sometech Incorporated has been cited for 8 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 Sometech Incorporated come from?
All FDA import refusal data for Sometech Incorporated 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.