Changchun Kangda Industry Co. Ltd.
⚠️ High Risk
FEI: 3000286306 • Changchun, Jilin • CHINA
FEI Number
3000286306
Location
Changchun, Jilin
Country
CHINAAddress
12 Pu Dong Road, , Changchun, Jilin, China
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
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).
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).
NO LICENSE
The article is subject to refusal of admission under section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) because it appears to be a biological product for which a biologics license is not in effect under the Public Health Service Act, Part F, Subpart 1-Biological Products, Section 351(a), and it is not the subject of an Investigational New Drug application that is in effect. Therefore, it appears to be a new drug under 201(p) of the FD&C Act that it is in violation of section 505(a) of the FD&C Act because it lacks a new drug approval and because it is misbranded under section 502(f)(1)of the FD&C Act because it fails to 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.
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).
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 8/4/2010 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 8/4/2010 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/1/2010 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 1/5/2010 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/8/2009 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | 341REGISTERED | Florida District Office (FLA-DO) |
| 12/8/2009 | 80BRZSET, BLOOD TRANSFUSION | 341REGISTERED | Florida District Office (FLA-DO) |
| 11/24/2009 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/31/2009 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | Division of Southeast Imports (DSEI) | |
| 1/26/2009 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 12/2/2008 | 80BRZSET, BLOOD TRANSFUSION | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 12/2/2008 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/20/2008 | 80BRZSET, BLOOD TRANSFUSION | Florida District Office (FLA-DO) | |
| 9/30/2008 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 9/24/2008 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 8/25/2008 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 27DRUG GMPS | Division of Southeast Imports (DSEI) |
| 8/11/2008 | 80BRZSET, BLOOD TRANSFUSION | Florida District Office (FLA-DO) | |
| 5/23/2008 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/14/2008 | 80BRZSET, BLOOD TRANSFUSION | Division of Southeast Imports (DSEI) | |
| 3/28/2008 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 2/26/2008 | 57YY02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 8/7/2007 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/7/2007 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 3/22/2007 | 80BRZSET, BLOOD TRANSFUSION | 341REGISTERED | Florida District Office (FLA-DO) |
| 3/22/2007 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 11/24/2006 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | Florida District Office (FLA-DO) | |
| 11/24/2006 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 10/31/2006 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | Florida District Office (FLA-DO) | |
| 10/31/2006 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 71NO LICENSE | Florida District Office (FLA-DO) |
| 10/11/2006 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | 341REGISTERED | Florida District Office (FLA-DO) |
| 10/11/2006 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/23/2006 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/23/2006 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/1/2006 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 71NO LICENSE | Florida District Office (FLA-DO) |
| 6/30/2006 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | Division of Southeast Imports (DSEI) | |
| 6/30/2006 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 4/27/2006 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | Division of Southeast Imports (DSEI) | |
| 3/28/2006 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/8/2006 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | Division of Southeast Imports (DSEI) | |
| 12/27/2005 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | Division of Southeast Imports (DSEI) | |
| 12/27/2005 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 71NO LICENSE | Florida District Office (FLA-DO) |
| 11/1/2005 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | Division of Southeast Imports (DSEI) | |
| 10/19/2005 | 78FCNKIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 78FCNKIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 78FCNKIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 78FCNKIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 78FCNKIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 78FCNKIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 78FCNKIT, URINARY DRAINAGE COLLECTION, FOR INDWELLING CATHETER | 341REGISTERED | Division of West Coast Imports (DWCI) |
| 10/19/2005 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/15/2005 | 73BSYCATHETERS, SUCTION, TRACHEOBRONCHIAL | 341REGISTERED | Los Angeles District Office (LOS-DO) |
| 10/6/2005 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 10/6/2005 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 9/26/2005 | 80FPASET, ADMINISTRATION, INTRAVASCULAR | 341REGISTERED | Florida District Office (FLA-DO) |
| 9/26/2005 | 78FAQBAG, URINE COLLECTION, LEG, FOR EXTERNAL USE | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/12/2005 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/17/2005 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/10/2005 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 6/10/2005 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/24/2005 | 80BRZSET, BLOOD TRANSFUSION | Division of Southeast Imports (DSEI) | |
| 2/15/2005 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 12/6/2004 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 71NO LICENSE | Division of Southeast Imports (DSEI) |
| 11/10/2004 | 78FAGPROSTHESIS, URETHRAL SPHINCTER | Florida District Office (FLA-DO) |
Frequently Asked Questions
What is Changchun Kangda Industry Co. Ltd.'s FDA import refusal history?
Changchun Kangda Industry Co. Ltd. (FEI: 3000286306) has 64 FDA import refusal record(s) in our database, spanning from 11/10/2004 to 8/4/2010.
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. Changchun Kangda Industry Co. Ltd.'s FEI number is 3000286306.
What types of violations has Changchun Kangda Industry Co. Ltd. received?
Changchun Kangda Industry 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 Changchun Kangda Industry Co. Ltd. come from?
All FDA import refusal data for Changchun Kangda Industry 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.