C WORLD KSG CORPORATION
⚠️ Moderate Risk
FEI: 3009526096 • Cavite, Calabarzon • PHILIPPINES
FEI Number
3009526096
Location
Cavite, Calabarzon
Country
PHILIPPINESAddress
NO 2 8th Street Golden Mile Business Par, , Cavite, Calabarzon, Philippines
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
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
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.
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.
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 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.
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).
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/30/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Division of Southeast Imports (DSEI) | |
| 9/6/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 2/17/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 78STERILITY | Division of Southeast Imports (DSEI) |
| 2/15/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 78STERILITY | Division of Southeast Imports (DSEI) |
| 2/9/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 78STERILITY | Division of Southeast Imports (DSEI) |
| 2/9/2017 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 78STERILITY | Division of Southeast Imports (DSEI) |
| 12/19/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 78STERILITY | Cincinnati District Office (CIN-DO) |
| 6/23/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 78STERILITY | Cincinnati District Office (CIN-DO) |
| 6/23/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 78STERILITY | Cincinnati District Office (CIN-DO) |
| 6/22/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 78STERILITY | Cincinnati District Office (CIN-DO) |
| 6/22/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 78STERILITY | Cincinnati District Office (CIN-DO) |
| 2/24/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 78STERILITY | Cincinnati District Office (CIN-DO) |
| 2/22/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 78STERILITY | Cincinnati District Office (CIN-DO) |
| 2/22/2016 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 78STERILITY | Cincinnati District Office (CIN-DO) |
| 12/1/2015 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | 78STERILITY | Cincinnati District Office (CIN-DO) |
| 6/27/2014 | 86MVNLENS, CONTACT (DISPOSABLE) | Division of Southeast Imports (DSEI) | |
| 8/16/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 8/16/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 8/16/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 8/16/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 8/16/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 8/16/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 8/16/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 8/16/2013 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | Cincinnati District Office (CIN-DO) | |
| 3/29/2012 | 86LPLLENSES, SOFT CONTACT, DAILY WEAR | San Francisco District Office (SAN-DO) |
Frequently Asked Questions
What is C WORLD KSG CORPORATION's FDA import refusal history?
C WORLD KSG CORPORATION (FEI: 3009526096) has 25 FDA import refusal record(s) in our database, spanning from 3/29/2012 to 11/30/2017.
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. C WORLD KSG CORPORATION's FEI number is 3009526096.
What types of violations has C WORLD KSG CORPORATION received?
C WORLD KSG CORPORATION has been cited for 7 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 C WORLD KSG CORPORATION come from?
All FDA import refusal data for C WORLD KSG CORPORATION 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.