Foretek Microsystem Co., Ltd.
⚠️ Moderate Risk
FEI: 3010226389 • Seoul • SOUTH KOREA
FEI Number
3010226389
Location
Seoul
Country
SOUTH KOREAAddress
4Fl, Seonjin Bldg., #35-11, Samseong-dong, Gangnam-gu, 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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
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.
Refusal History
Frequently Asked Questions
What is Foretek Microsystem Co., Ltd.'s FDA import refusal history?
Foretek Microsystem Co., Ltd. (FEI: 3010226389) has 1 FDA import refusal record(s) in our database, spanning from 7/24/2013 to 7/24/2013.
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. Foretek Microsystem Co., Ltd.'s FEI number is 3010226389.
What types of violations has Foretek Microsystem Co., Ltd. received?
Foretek Microsystem Co., Ltd. has been cited for 3 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 Foretek Microsystem Co., Ltd. come from?
All FDA import refusal data for Foretek Microsystem Co., Ltd. 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.