K J I Industrial Co., Ltd.
⚠️ Moderate Risk
FEI: 3004096641 • Gyeongsangnam-do • SOUTH KOREA
FEI Number
3004096641
Location
Gyeongsangnam-do
Country
SOUTH KOREAAddress
29 Gyeseok-ro, Dong-myeon, , Yangsan-si, Gyeongsangnam-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
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).
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).
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.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
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 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).
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 4/25/2022 | 53LY02DEPILATORIES (SKIN CARE PREPARATIONS) | 27DRUG GMPS | Division of Northern Border Imports (DNBI) |
| 8/5/2015 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Cincinnati District Office (CIN-DO) | |
| 5/30/2008 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 5/23/2008 | 66VBY99MISCELLANEOUS PATENT MEDICINES, ETC. | 16DIRECTIONS | Seattle District Office (SEA-DO) |
| 4/19/2008 | 80FQMBANDAGE, ELASTIC | Los Angeles District Office (LOS-DO) | |
| 3/25/2008 | 80FQMBANDAGE, ELASTIC | Seattle District Office (SEA-DO) | |
| 5/25/2007 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 3/28/2007 | 66YBI99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | Seattle District Office (SEA-DO) | |
| 12/12/2006 | 80FQMBANDAGE, ELASTIC | Seattle District Office (SEA-DO) | |
| 12/1/2006 | 89MLXPAD, MEDICATED, ADHESIVE, NON-ELECTRIC | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is K J I Industrial Co., Ltd.'s FDA import refusal history?
K J I Industrial Co., Ltd. (FEI: 3004096641) has 10 FDA import refusal record(s) in our database, spanning from 12/1/2006 to 4/25/2022.
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. K J I Industrial Co., Ltd.'s FEI number is 3004096641.
What types of violations has K J I Industrial Co., Ltd. received?
K J I Industrial Co., Ltd. has been cited for 9 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 K J I Industrial Co., Ltd. come from?
All FDA import refusal data for K J I Industrial 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.