Shanghai Kindly Enterprise Development Group Co., Ltd.
⚠️ Moderate Risk
FEI: 3004577167 • Shanghai, Shanghai • CHINA
FEI Number
3004577167
Location
Shanghai, Shanghai
Country
CHINAAddress
No. 170 Huajiang Rd., Jiading, Shanghai, Shanghai, 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
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 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.
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).
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.
NON STD
The article is subject to refusal of admission pursuant to section 536(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) in that it appears to be an electronic product offered for importation into the United States which fails to comply with an applicable standard prescribed pursuant to section 534 of the FFDCA.
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
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 9/13/2013 | 80FLKTHERMOMETER, CLINICAL MERCURY | Division of Southeast Imports (DSEI) | |
| 10/18/2010 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | Division of Southeast Imports (DSEI) | |
| 3/1/2010 | 80FMFSYRINGE, PISTON | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 2/26/2010 | 80FMFSYRINGE, PISTON | 341REGISTERED | Florida District Office (FLA-DO) |
| 12/1/2009 | 80FMFSYRINGE, PISTON | Division of Southeast Imports (DSEI) | |
| 10/13/2009 | 80FMFSYRINGE, PISTON | 118NOT LISTED | Florida District Office (FLA-DO) |
| 8/13/2009 | 80FMFSYRINGE, PISTON | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 7/6/2009 | 80FMFSYRINGE, PISTON | 47NON STD | Division of Southeast Imports (DSEI) |
| 6/24/2009 | 80FMFSYRINGE, PISTON | Division of Southeast Imports (DSEI) | |
| 12/10/2008 | 80FMFSYRINGE, PISTON | 341REGISTERED | Florida District Office (FLA-DO) |
| 9/21/2007 | 80FMFSYRINGE, PISTON | 341REGISTERED | Division of Southeast Imports (DSEI) |
| 3/22/2007 | 80FMFSYRINGE, PISTON | 341REGISTERED | Florida District Office (FLA-DO) |
| 1/22/2007 | 80FMFSYRINGE, PISTON | Florida District Office (FLA-DO) | |
| 9/12/2006 | 80FLKTHERMOMETER, CLINICAL MERCURY | 341REGISTERED | Florida District Office (FLA-DO) |
| 9/12/2006 | 80FLKTHERMOMETER, CLINICAL MERCURY | 341REGISTERED | Florida District Office (FLA-DO) |
| 4/5/2006 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | Division of Southeast Imports (DSEI) | |
| 3/15/2006 | 80FMINEEDLE, HYPODERMIC, SINGLE LUMEN | 341REGISTERED | Florida District Office (FLA-DO) |
| 8/5/2005 | 80KZHINTRODUCER, SYRINGE NEEDLE | Division of Southeast Imports (DSEI) | |
| 7/28/2005 | 80KZHINTRODUCER, SYRINGE NEEDLE | Florida District Office (FLA-DO) | |
| 4/6/2005 | 80KZHINTRODUCER, SYRINGE NEEDLE | Division of Southeast Imports (DSEI) | |
| 2/28/2005 | 81KSRCONTAINER, EMPTY, FOR COLLECTION & PROCESSING OF BLOOD & BLOOD COMPONENTS | Division of Southeast Imports (DSEI) | |
| 2/15/2005 | 57YH02BLOOD BAGS WITH ANTI-COAGULANT PRIOR TO USE | 118NOT LISTED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is Shanghai Kindly Enterprise Development Group Co., Ltd.'s FDA import refusal history?
Shanghai Kindly Enterprise Development Group Co., Ltd. (FEI: 3004577167) has 22 FDA import refusal record(s) in our database, spanning from 2/15/2005 to 9/13/2013.
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. Shanghai Kindly Enterprise Development Group Co., Ltd.'s FEI number is 3004577167.
What types of violations has Shanghai Kindly Enterprise Development Group Co., Ltd. received?
Shanghai Kindly Enterprise Development Group 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 Shanghai Kindly Enterprise Development Group Co., Ltd. come from?
All FDA import refusal data for Shanghai Kindly Enterprise Development Group 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.