Newbio Co Ltd
⚠️ Moderate Risk
FEI: 3010340706 • Kyonggi-do • SOUTH KOREA
FEI Number
3010340706
Location
Kyonggi-do
Country
SOUTH KOREAAddress
675-2 Poongmoo Dong Gimpo-Si, , Kyonggi-do, , 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(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.
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.
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
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/20/2013 | 86MVNLENS, CONTACT (DISPOSABLE) | New Orleans District Office (NOL-DO) | |
| 12/18/2013 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | New Orleans District Office (NOL-DO) | |
| 12/18/2013 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | New Orleans District Office (NOL-DO) | |
| 11/19/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | New Orleans District Office (NOL-DO) | |
| 11/5/2013 | 86MWLLENS, CONTACT (RIGID GAS PERMEABLE) - EXTENDED WEAR | New Orleans District Office (NOL-DO) | |
| 10/30/2013 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | New Orleans District Office (NOL-DO) | |
| 10/30/2013 | 86MWLLENS, CONTACT (RIGID GAS PERMEABLE) - EXTENDED WEAR | New Orleans District Office (NOL-DO) | |
| 10/29/2013 | 86LPMLENSES, SOFT CONTACT, EXTENDED WEAR | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Newbio Co Ltd's FDA import refusal history?
Newbio Co Ltd (FEI: 3010340706) has 8 FDA import refusal record(s) in our database, spanning from 10/29/2013 to 12/20/2013.
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. Newbio Co Ltd's FEI number is 3010340706.
What types of violations has Newbio Co Ltd received?
Newbio Co Ltd has been cited for 6 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 Newbio Co Ltd come from?
All FDA import refusal data for Newbio 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.