YIWU BANGMEI MEDICAL PRODUCTS
⚠️ High Risk
FEI: 3008973760 • Jinhua, Zhejiang • CHINA
FEI Number
3008973760
Location
Jinhua, Zhejiang
Country
CHINAAddress
D, Belyuan, NO. 10 Jing Sanlu; Yiwu, Jinhua, Zhejiang, 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
LBLG ADVER
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be misbranded because its labeling is misleading in a particular, namely that it fails to reveal facts (non-sterility) that are material with respect to consequences which may result from the use of the article according to the labeling, or advertising, or under such conditions of use as are customary or usual.
POSS N/STR
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance, namely, potentially infectious organisms
STERILITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to have been prepared, packed or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health.
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).
DV QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be adulterated since its strength differs from, or its purity or quality falls below, that which it purports or is represented to possess.
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.
STERILITY
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 3/23/2017 | 79OHOFIRST AID KIT WITHOUT DRUG | Division of Southwest Imports (DSWI) | |
| 4/15/2016 | 80KGXTAPE AND BANDAGE, ADHESIVE | Los Angeles District Office (LOS-DO) | |
| 1/8/2016 | 80KGXTAPE AND BANDAGE, ADHESIVE | Los Angeles District Office (LOS-DO) | |
| 8/5/2015 | 79OHOFIRST AID KIT WITHOUT DRUG | 2800POSS N/STR | Los Angeles District Office (LOS-DO) |
| 8/5/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | 479DV QUALITY | Los Angeles District Office (LOS-DO) |
| 6/12/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | 2800POSS N/STR | Atlanta District Office (ATL-DO) |
| 6/2/2015 | 79OHOFIRST AID KIT WITHOUT DRUG | Baltimore District Office (BLT-DO) | |
| 4/16/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | San Francisco District Office (SAN-DO) | |
| 4/15/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | Baltimore District Office (BLT-DO) | |
| 4/15/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | Baltimore District Office (BLT-DO) | |
| 4/15/2015 | 79OHOFIRST AID KIT WITHOUT DRUG | Baltimore District Office (BLT-DO) | |
| 3/12/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | 2800POSS N/STR | Division of Southeast Imports (DSEI) |
| 2/25/2015 | 80KGXTAPE AND BANDAGE, ADHESIVE | 304STERILITY | Southwest Import District Office (SWI-DO) |
Frequently Asked Questions
What is YIWU BANGMEI MEDICAL PRODUCTS's FDA import refusal history?
YIWU BANGMEI MEDICAL PRODUCTS (FEI: 3008973760) has 13 FDA import refusal record(s) in our database, spanning from 2/25/2015 to 3/23/2017.
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. YIWU BANGMEI MEDICAL PRODUCTS's FEI number is 3008973760.
What types of violations has YIWU BANGMEI MEDICAL PRODUCTS received?
YIWU BANGMEI MEDICAL PRODUCTS has been cited for 8 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 YIWU BANGMEI MEDICAL PRODUCTS come from?
All FDA import refusal data for YIWU BANGMEI MEDICAL PRODUCTS 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.