FOSHAN NANHAI YUSHENG SANITARY PRODUCTS LTD CO
⚠️ Moderate Risk
FEI: 3006895661 • Guangdong State • CHINA
FEI Number
3006895661
Location
Guangdong State
Country
CHINAAddress
Shibu Ind Estate Dali Town, , Guangdong State, , 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
NO REGISTR
The article appears to be an electronic product that does not comply with an applicable standard as prescribed by Section 534 because no reporting has been provided as required by Section 537(b).
NO 510(K)
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed.
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.
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/28/2013 | 79NRJULTRASOUND, SKIN PERMEATION | Detroit District Office (DET-DO) | |
| 4/25/2011 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) | |
| 4/25/2011 | 89ISAMASSAGER, THERAPEUTIC, ELECTRIC | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is FOSHAN NANHAI YUSHENG SANITARY PRODUCTS LTD CO's FDA import refusal history?
FOSHAN NANHAI YUSHENG SANITARY PRODUCTS LTD CO (FEI: 3006895661) has 3 FDA import refusal record(s) in our database, spanning from 4/25/2011 to 10/28/2013.
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. FOSHAN NANHAI YUSHENG SANITARY PRODUCTS LTD CO's FEI number is 3006895661.
What types of violations has FOSHAN NANHAI YUSHENG SANITARY PRODUCTS LTD CO received?
FOSHAN NANHAI YUSHENG SANITARY PRODUCTS LTD CO has been cited for 5 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 FOSHAN NANHAI YUSHENG SANITARY PRODUCTS LTD CO come from?
All FDA import refusal data for FOSHAN NANHAI YUSHENG SANITARY PRODUCTS LTD CO 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.