Shanghai Multi-Med Union Co., Ltd
⚠️ High Risk
FEI: 3006477134 • Shanghai, Shanghai • CHINA
FEI Number
3006477134
Location
Shanghai, Shanghai
Country
CHINAAddress
Zhongshan Wumao Dasha Floor 20 Room 2018, , Shanghai, Shanghai, 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
DE IMP GMP
The article is subject to refusal of admission pursuant to section 801(a)(1) in that it appears that the methods used in, or the facilities or controls used for, the manufacture of the device do not conform to the applicable requirements of section 520(f).
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).
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).
DIRECTIONS
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose label appears to not bear adequate directions for use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 12/30/2011 | 79FMKSINGLE USE ONLY BLOOD LANCET WITH AN INTEGRAL SHARPS INJURY PREVENTION FEATURE | 118NOT LISTED | New Orleans District Office (NOL-DO) |
| 8/23/2011 | 62ICY24HYDROXYUREA (ANTI-NEOPLASTIC) | New Orleans District Office (NOL-DO) | |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 84HAERONGEUR, MANUAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 9/20/2010 | 79LRWSCISSORS, GENERAL USE, SURGICAL | 290DE IMP GMP | New England District Office (NWE-DO) |
| 4/2/2010 | 60CAS54BRIMONIDINE TARTRATE (ADRENERGIC) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 3/9/2010 | 62OAS35GUANABENZ ACETATE (ANTI-HYPERTENSIVE - PART II) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 11/3/2009 | 56PAS01LINEZOLID (OXAZOLIDINONE) | 118NOT LISTED | Los Angeles District Office (LOS-DO) |
| 8/5/2008 | 66VDY99MISCELLANEOUS PATENT MEDICINES, ETC. | Seattle District Office (SEA-DO) |
Frequently Asked Questions
What is Shanghai Multi-Med Union Co., Ltd's FDA import refusal history?
Shanghai Multi-Med Union Co., Ltd (FEI: 3006477134) has 45 FDA import refusal record(s) in our database, spanning from 8/5/2008 to 12/30/2011.
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 Multi-Med Union Co., Ltd's FEI number is 3006477134.
What types of violations has Shanghai Multi-Med Union Co., Ltd received?
Shanghai Multi-Med Union Co., Ltd has been cited for 4 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 Multi-Med Union Co., Ltd come from?
All FDA import refusal data for Shanghai Multi-Med Union 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.