Yangzhou Holyshine Industrial Co., Ltd.
⚠️ Moderate Risk
FEI: 3010568100 • Yangzhou, Jiangsu • CHINA
FEI Number
3010568100
Location
Yangzhou, Jiangsu
Country
CHINAAddress
No. 15 Taoyuan Road, Guangling, 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).
DR QUALITY
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the article appears to be represented as a drug the name of which is recognized in an official compendium and its strength appears to differ from or its quality or purity appear to fall below the standards set forth in such compendium.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 2/12/2018 | 63RBJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of Northern Border Imports (DNBI) | |
| 2/12/2018 | 63RBJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | Division of Northern Border Imports (DNBI) | |
| 9/18/2017 | 63RBJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
| 9/18/2017 | 63RBJ05SODIUM MONOFLUOROPHOSPHATE (DENTAL CARIES PROPHYLACTIC) | 118NOT LISTED | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Yangzhou Holyshine Industrial Co., Ltd.'s FDA import refusal history?
Yangzhou Holyshine Industrial Co., Ltd. (FEI: 3010568100) has 4 FDA import refusal record(s) in our database, spanning from 9/18/2017 to 2/12/2018.
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 Holyshine Industrial Co., Ltd.'s FEI number is 3010568100.
What types of violations has Yangzhou Holyshine Industrial Co., Ltd. received?
Yangzhou Holyshine Industrial Co., Ltd. has been cited for 2 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 Holyshine Industrial Co., Ltd. come from?
All FDA import refusal data for Yangzhou Holyshine Industrial 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.