Shenyng Pharon Health Produsts Co Ltd
⚠️ Moderate Risk
FEI: 1000397259 • Shenyang • CHINA
FEI Number
1000397259
Location
Shenyang
Country
CHINAAddress
41 Wenhua Road Heping District, , Shenyang, , 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).
UNAPPROVED
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it appears to be a new drug within the meaning of Section 201(p) without an approved New Drug Application (NDA).
UNSFDIETSP
The article appears to be a dietary supplement or ingredient for which there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury.
UNSFDIETLB
The article appears to be a dietary supplement or contain a dietary ingredient that presents a significant or unreasonable risk of illness or injury under the conditions of use set out in the labeling or, if none are set out in the labeling, under customary conditions of use.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 10/5/2004 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | 2120UNSFDIETSP | Los Angeles District Office (LOS-DO) |
| 10/5/2004 | 54FCR99HERBALS & BOTANICALS (NOT TEAS), N.E.C. | Los Angeles District Office (LOS-DO) | |
| 7/24/2004 | 66VDA99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
| 6/1/2004 | 66YDA99EXHIBITS - OTHER DRUG RELATED ITEMS N.E.C. | 118NOT LISTED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Shenyng Pharon Health Produsts Co Ltd's FDA import refusal history?
Shenyng Pharon Health Produsts Co Ltd (FEI: 1000397259) has 4 FDA import refusal record(s) in our database, spanning from 6/1/2004 to 10/5/2004.
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. Shenyng Pharon Health Produsts Co Ltd's FEI number is 1000397259.
What types of violations has Shenyng Pharon Health Produsts Co Ltd received?
Shenyng Pharon Health Produsts Co Ltd has been cited for 4 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 Shenyng Pharon Health Produsts Co Ltd come from?
All FDA import refusal data for Shenyng Pharon Health Produsts 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.