Henan Kangdi Medical Devices Co. Ltd
⚠️ Moderate Risk
FEI: 3009271465 • Zhoukou, Henan • CHINA
FEI Number
3009271465
Location
Zhoukou, Henan
Country
CHINAAddress
Sme Pioneer Park, No. 4 2nd Area, Zhoukou, Henan, China
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).
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).
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and 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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/13/2019 | 60QBY67LIDOCAINE (ANESTHETIC) | 27DRUG GMPS | Division of West Coast Imports (DWCI) |
| 10/28/2019 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Division of Northeast Imports (DNEI) | |
| 8/12/2019 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 8/12/2019 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/12/2017 | 66YBD99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 6/14/2017 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Southeast Imports (DSEI) | |
| 6/5/2017 | 53LD01CLEANSING (COLD CREAMS, CLEANSING LOTIONS, LIQUIDS, PADS) (SKIN CARE PREPARATIONS) | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
| 7/29/2016 | 60LDD99ANALGESIC, N.E.C. | Minneapolis District Office (MIN-DO) | |
| 2/18/2016 | 60MAY04DURAGESIC | 118NOT LISTED | Atlanta District Office (ATL-DO) |
| 5/4/2012 | 66VDL99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Henan Kangdi Medical Devices Co. Ltd's FDA import refusal history?
Henan Kangdi Medical Devices Co. Ltd (FEI: 3009271465) has 10 FDA import refusal record(s) in our database, spanning from 5/4/2012 to 12/13/2019.
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. Henan Kangdi Medical Devices Co. Ltd's FEI number is 3009271465.
What types of violations has Henan Kangdi Medical Devices Co. Ltd received?
Henan Kangdi Medical Devices 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 Henan Kangdi Medical Devices Co. Ltd come from?
All FDA import refusal data for Henan Kangdi Medical Devices 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.