MAX LOOK CONTACT LENS / KIM
⚠️ High Risk
FEI: 3009535809 • Gyeongsan, Gyeongsangbugdo • SOUTH KOREA
FEI Number
3009535809
Location
Gyeongsan, Gyeongsangbugdo
Country
SOUTH KOREAAddress
105 Hyeopseok-Ri, Namcheon-Myeon, Gyeongsan, Gyeongsangbugdo, South Korea
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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.
STERILITY
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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.
MFR INSAN
The article is subject to refusal of admission pursuant to section 801(a)(1) in that the article appears to have been manufactured, processed, or packed under insanitary conditions.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 5/21/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Baltimore District Office (BLT-DO) | |
| 4/3/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 4/3/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 4/3/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 4/3/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2780DEVICEGMPS | Cincinnati District Office (CIN-DO) |
| 4/3/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 11/30/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/30/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/30/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
| 11/30/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2780DEVICEGMPS | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is MAX LOOK CONTACT LENS / KIM's FDA import refusal history?
MAX LOOK CONTACT LENS / KIM (FEI: 3009535809) has 10 FDA import refusal record(s) in our database, spanning from 11/30/2012 to 5/21/2013.
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. MAX LOOK CONTACT LENS / KIM's FEI number is 3009535809.
What types of violations has MAX LOOK CONTACT LENS / KIM received?
MAX LOOK CONTACT LENS / KIM 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 MAX LOOK CONTACT LENS / KIM come from?
All FDA import refusal data for MAX LOOK CONTACT LENS / KIM 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.