BEIJING MANSON TECH CO.,LTD
⚠️ Moderate Risk
FEI: 3013510287 • Beijing • 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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 1/30/2019 | 81ORGPLATELET AND PLASMA SEPARATOR FOR BONE GRAFT HANDLING | Division of Southeast Imports (DSEI) | |
| 4/18/2018 | 79KCWEPILATOR, HIGH FREQUENCY, NEEDLE-TYPE | Division of Southeast Imports (DSEI) | |
| 2/6/2018 | 81GIOTUBE, COLLECTION, CAPILLARY BLOOD | 118NOT LISTED | Division of Southeast Imports (DSEI) |
| 7/3/2017 | 75GIMTUBES, VACUUM SAMPLE, WITH ANTICOAGULANT | 75UNAPPROVED | Division of Southeast Imports (DSEI) |
Frequently Asked Questions
What is BEIJING MANSON TECH CO.,LTD's FDA import refusal history?
BEIJING MANSON TECH CO.,LTD (FEI: 3013510287) has 4 FDA import refusal record(s) in our database, spanning from 7/3/2017 to 1/30/2019.
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. BEIJING MANSON TECH CO.,LTD's FEI number is 3013510287.
What types of violations has BEIJING MANSON TECH CO.,LTD received?
BEIJING MANSON TECH 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 BEIJING MANSON TECH CO.,LTD come from?
All FDA import refusal data for BEIJING MANSON TECH 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.