Changchun Wancheng Bio-Electron Co., Ltd.
⚠️ Moderate Risk
FEI: 3008987086 • Changchun, Jilin • CHINA
FEI Number
3008987086
Location
Changchun, Jilin
Country
CHINAAddress
Building 4 Floor 5, No. 388 Huoju Road, Changchun, Jilin, 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
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.
LACKS FIRM
The article is in package form and appears to not bear a label containing the name and place of business of the manufacturer, packer, or distributor.
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.
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 |
|---|---|---|---|
| 5/10/2022 | 83JXAKIT, SCREENING, URINE | Division of Southeast Imports (DSEI) | |
| 5/10/2022 | 85LNWPAPER, OBSTETRIC PH | Division of Southeast Imports (DSEI) | |
| 4/19/2021 | 75OTVRESEARCH USE ONLY/CLINICAL CHEMISTRY DEVICES | Division of Southeast Imports (DSEI) | |
| 11/6/2020 | 75CENDYE-INDICATOR, PH (URINARY, NON-QUANT.) | Division of Southeast Imports (DSEI) | |
| 7/30/2020 | 83QKPCORONAVIRUS ANTIGEN DETECTION TEST SYSTEM. | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 6/5/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | Division of Northern Border Imports (DNBI) | |
| 5/29/2020 | 83QKOREAGENT, CORONAVIRUS SEROLOGICAL | 508NO 510(K) | Division of Southeast Imports (DSEI) |
| 8/7/2018 | 91DNCSTRIP, PAPER, SALICYLATE | Division of Northern Border Imports (DNBI) | |
| 8/14/2017 | 75CENDYE-INDICATOR, PH (URINARY, NON-QUANT.) | Division of Southeast Imports (DSEI) | |
| 4/3/2017 | 78NTZSTRIP, DIALYSATE, PH, BICARBONATE, GLUCOSE, ACID, INDICATOR | 333LACKS FIRM | Division of Southeast Imports (DSEI) |
| 2/18/2016 | 75CENDYE-INDICATOR, PH (URINARY, NON-QUANT.) | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Changchun Wancheng Bio-Electron Co., Ltd.'s FDA import refusal history?
Changchun Wancheng Bio-Electron Co., Ltd. (FEI: 3008987086) has 11 FDA import refusal record(s) in our database, spanning from 2/18/2016 to 5/10/2022.
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. Changchun Wancheng Bio-Electron Co., Ltd.'s FEI number is 3008987086.
What types of violations has Changchun Wancheng Bio-Electron Co., Ltd. received?
Changchun Wancheng Bio-Electron Co., Ltd. has been cited for 5 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 Wancheng Bio-Electron Co., Ltd. come from?
All FDA import refusal data for Changchun Wancheng Bio-Electron 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.