Korea Mok Cho Co Ltd
⚠️ High Risk
FEI: 3005007557 • Chungcheongnam • SOUTH KOREA
FEI Number
3005007557
Location
Chungcheongnam
Country
SOUTH KOREAAddress
110-1 Samsung Dong, Dong Gu, , Daejeon, Chungcheongnam, , 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
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
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.
POISONOUS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to bear or contain a poisonous or deleterious substance which may render the article injurious to health. Contains:
DANGEROUS
The article appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof.
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 |
|---|---|---|---|
| 8/21/2007 | 80FRLFIBER, MEDICAL, ABSORBENT | Seattle District Office (SEA-DO) | |
| 2/27/2007 | 80FRLFIBER, MEDICAL, ABSORBENT | Seattle District Office (SEA-DO) | |
| 8/30/2006 | 53LF01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Seattle District Office (SEA-DO) |
| 6/9/2006 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/9/2006 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/9/2006 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/9/2006 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/27/2006 | 66VCY99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 4/26/2006 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Seattle District Office (SEA-DO) | |
| 10/13/2005 | 89ILJBATH, HYDRO-MASSAGE | Los Angeles District Office (LOS-DO) | |
| 10/13/2005 | 89ILJBATH, HYDRO-MASSAGE | Los Angeles District Office (LOS-DO) | |
| 10/13/2005 | 89ILJBATH, HYDRO-MASSAGE | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/13/2005 | 89ILJBATH, HYDRO-MASSAGE | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/13/2005 | 89ILJBATH, HYDRO-MASSAGE | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 10/13/2005 | 65NCY99RADIOACTIVE AGENT N.E.C. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 3/31/2005 | 80FRLFIBER, MEDICAL, ABSORBENT | 16DIRECTIONS | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Korea Mok Cho Co Ltd's FDA import refusal history?
Korea Mok Cho Co Ltd (FEI: 3005007557) has 16 FDA import refusal record(s) in our database, spanning from 3/31/2005 to 8/21/2007.
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. Korea Mok Cho Co Ltd's FEI number is 3005007557.
What types of violations has Korea Mok Cho Co Ltd received?
Korea Mok Cho Co Ltd 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 Korea Mok Cho Co Ltd come from?
All FDA import refusal data for Korea Mok Cho 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.