Shanghai Care US Medical Product Co., Ltd
⚠️ High Risk
FEI: 3010700223 • Shanghai, Shanghai • CHINA
FEI Number
3010700223
Location
Shanghai, Shanghai
Country
CHINAAddress
No.2, Lane 10, West Chenchuan Road, Baoshan District, 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
STERILITY
The article appears to consist in whole or in part of any filthy, putrid, or decomposed substance.
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.
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.
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).
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.
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.
LABELING
The article appears in violation of FPLA because of its placement, form and/or contents statement.
STD LABEL
The article appears to not bear labeling prescribed by the performance standard established under section 514.
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.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 11/20/2025 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Southeast Imports (DSEI) | |
| 9/24/2025 | 79OJJBURN KIT WITHOUT DRUG | 304STERILITY | Division of West Coast Imports (DWCI) |
| 9/24/2025 | 79OHOFIRST AID KIT WITHOUT DRUG | 304STERILITY | Division of West Coast Imports (DWCI) |
| 9/15/2025 | 79KGXTAPE AND BANDAGE, ADHESIVE | Division of Southeast Imports (DSEI) | |
| 9/9/2025 | 79OJJBURN KIT WITHOUT DRUG | 78STERILITY | Division of West Coast Imports (DWCI) |
| 9/9/2025 | 80FQMBANDAGE, ELASTIC | 78STERILITY | Division of West Coast Imports (DWCI) |
| 9/9/2025 | 80FQMBANDAGE, ELASTIC | 78STERILITY | Division of West Coast Imports (DWCI) |
| 9/9/2025 | 80FQMBANDAGE, ELASTIC | 78STERILITY | Division of West Coast Imports (DWCI) |
| 6/9/2025 | 89IMDPACK, HOT OR COLD, DISPOSABLE | Division of Northern Border Imports (DNBI) | |
| 6/9/2025 | 79LRRKIT, FIRST AID | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Shanghai Care US Medical Product Co., Ltd's FDA import refusal history?
Shanghai Care US Medical Product Co., Ltd (FEI: 3010700223) has 10 FDA import refusal record(s) in our database, spanning from 6/9/2025 to 11/20/2025.
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 Care US Medical Product Co., Ltd's FEI number is 3010700223.
What types of violations has Shanghai Care US Medical Product Co., Ltd received?
Shanghai Care US Medical Product Co., Ltd has been cited for 9 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 Care US Medical Product Co., Ltd come from?
All FDA import refusal data for Shanghai Care US Medical Product 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.