WELLSPRING MEDICAL SUPPLIES CO., LTD.
✅ Low Risk
FEI: 3006948285 • Shanghai, Shanghai • CHINA
FEI Number
3006948285
Location
Shanghai, Shanghai
Country
CHINAAddress
Add Room A215 No. 98, Zhongshan Road(E), NO. 135 FutebeiluNO. 1 R.D (W), Shanghai, Shanghai, China
Low Risk
FDA Import Risk Assessment
This firm has a minimal history of FDA import refusals with low-severity 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
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.
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.
INCONSPICU
Information required by the Act to be on the label or labeling does not appear to be conspicuous enough as to render it likely to be read and understood by the ordinary individual under customary conditions of purchase and use.
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 NAME
The article appears to be a device and its labeling fails to bear the proprietary or established name.
Refusal History
Frequently Asked Questions
What is WELLSPRING MEDICAL SUPPLIES CO., LTD.'s FDA import refusal history?
WELLSPRING MEDICAL SUPPLIES CO., LTD. (FEI: 3006948285) has 1 FDA import refusal record(s) in our database, spanning from 8/24/2011 to 8/24/2011.
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. WELLSPRING MEDICAL SUPPLIES CO., LTD.'s FEI number is 3006948285.
What types of violations has WELLSPRING MEDICAL SUPPLIES CO., LTD. received?
WELLSPRING MEDICAL SUPPLIES 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 WELLSPRING MEDICAL SUPPLIES CO., LTD. come from?
All FDA import refusal data for WELLSPRING MEDICAL SUPPLIES 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.