Shanghai Multimed Union Co., LTD.
⚠️ Moderate Risk
FEI: 3004265165 • Shanghai, Shanghai • CHINA
FEI Number
3004265165
Location
Shanghai, Shanghai
Country
CHINAAddress
No. 1958 Zhongshan Road,Building 20, Putuo District, 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
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).
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.
FALSE
The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading.
DRUG GMPS
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the methods used in and controls used for the manufacture, processing, packing, or holding of drugs and other products do not appear to conform to current good manufacturing practices within the meaning of Section 501(a)(2)(B).
NEW VET DR
The article is subject to refusal of admission pursuant to Section 801(a)(3) of the Federal Food, Drug, and Cosmetic Act in that it appears to be a new animal drug that is unsafe within the meaning of Section 512(a) of the Federal Food, Drug, and Cosmetic Act as it is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing, and no investigational new animal drug exemption applies.
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 |
|---|---|---|---|
| 11/29/2006 | 62CAS45PHENOXYBENZAMINE HCL (ANTI-HYPERTENSIVE) | Seattle District Office (SEA-DO) | |
| 8/20/2004 | 60CCR09PHENYLEPHRINE HCL (ADRENERGIC) | Seattle District Office (SEA-DO) | |
| 6/23/2004 | 64RBZ18HUMAN GROWTH HORMONE (HORMONE) | Cincinnati District Office (CIN-DO) | |
| 2/5/2002 | 61GAR47SULFADIAZINE (ANTI-BACTERIAL) (NOT ANTIBIOTIC) | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Shanghai Multimed Union Co., LTD.'s FDA import refusal history?
Shanghai Multimed Union Co., LTD. (FEI: 3004265165) has 4 FDA import refusal record(s) in our database, spanning from 2/5/2002 to 11/29/2006.
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 Multimed Union Co., LTD.'s FEI number is 3004265165.
What types of violations has Shanghai Multimed Union Co., LTD. received?
Shanghai Multimed Union 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 Multimed Union Co., LTD. come from?
All FDA import refusal data for Shanghai Multimed 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.