LAON CO, LTD
⚠️ Moderate Risk
FEI: 3006618034 • Siheung • SOUTH KOREA
FEI Number
3006618034
Location
Siheung
Country
SOUTH KOREAAddress
Siwha Industrial Complex, 2172-5 Jeongwangng, Siheung, , 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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/15/2013 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Los Angeles District Office (LOS-DO) | |
| 4/15/2013 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Los Angeles District Office (LOS-DO) | |
| 4/15/2013 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Los Angeles District Office (LOS-DO) | |
| 4/15/2013 | 80MQXNEEDLE, ACUPUNCTURE, SINGLE USE | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is LAON CO, LTD's FDA import refusal history?
LAON CO, LTD (FEI: 3006618034) has 4 FDA import refusal record(s) in our database, spanning from 4/15/2013 to 4/15/2013.
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. LAON CO, LTD's FEI number is 3006618034.
What types of violations has LAON CO, LTD received?
LAON CO, LTD 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 LAON CO, LTD come from?
All FDA import refusal data for LAON 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.