YANGZHOU ROYAL HOME PRODUCTS MANUFACTURE CO., LTD.
⚠️ Moderate Risk
FEI: 3006206362 • Jiangsu • CHINA
FEI Number
3006206362
Location
Jiangsu
Country
CHINAAddress
922-923, 28# WANHONG CITY, GARDEN, YANGZHOU, Jiangsu, , 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).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/5/2011 | 76EFWTOOTHBRUSH, MANUAL | Florida District Office (FLA-DO) | |
| 9/11/2007 | 76EFWTOOTHBRUSH, MANUAL | 118NOT LISTED | San Juan District Office (SJN-DO) |
| 9/11/2007 | 53IG01DENTIFRICES (AEROSOL, LIQUID, TOOTHPASTES, TOOTHPOWDERS), WITHOUT FLUORIDE (ORAL HYGIENE PRODUCTS) | San Juan District Office (SJN-DO) |
Frequently Asked Questions
What is YANGZHOU ROYAL HOME PRODUCTS MANUFACTURE CO., LTD.'s FDA import refusal history?
YANGZHOU ROYAL HOME PRODUCTS MANUFACTURE CO., LTD. (FEI: 3006206362) has 3 FDA import refusal record(s) in our database, spanning from 9/11/2007 to 10/5/2011.
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. YANGZHOU ROYAL HOME PRODUCTS MANUFACTURE CO., LTD.'s FEI number is 3006206362.
What types of violations has YANGZHOU ROYAL HOME PRODUCTS MANUFACTURE CO., LTD. received?
YANGZHOU ROYAL HOME PRODUCTS MANUFACTURE CO., LTD. has been cited for 3 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 YANGZHOU ROYAL HOME PRODUCTS MANUFACTURE CO., LTD. come from?
All FDA import refusal data for YANGZHOU ROYAL HOME PRODUCTS MANUFACTURE 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.