Linyi Taihao International Trading
⚠️ Moderate Risk
FEI: 3008314801 • Shandong • CHINA
FEI Number
3008314801
Location
Shandong
Country
CHINAAddress
Rm 501 Jinrun Commerce Mansionno109, , Shandong, , 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).
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).
NO PMA
The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1).
NO PMA/PDP
The article appears to be a class III dev.w/o an approved applic. for premarket approval, and/or a notice of completion of product development protocol filed per section 515(b) or exempt per sect.520(g)(1).
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).
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 6/24/2010 | 53LY99OTHER SKIN CARE PREPARATIONS, N.E.C. | Los Angeles District Office (LOS-DO) | |
| 6/1/2010 | 53LY10WRINKLE SMOOTHING (SKIN CARE PREPARATIONS) | Los Angeles District Office (LOS-DO) | |
| 5/20/2010 | 66ALY01HYALURONIDASE (FOR INJECTIONS) (SPREADING AGENT) | 75UNAPPROVED | Los Angeles District Office (LOS-DO) |
Frequently Asked Questions
What is Linyi Taihao International Trading's FDA import refusal history?
Linyi Taihao International Trading (FEI: 3008314801) has 3 FDA import refusal record(s) in our database, spanning from 5/20/2010 to 6/24/2010.
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. Linyi Taihao International Trading's FEI number is 3008314801.
What types of violations has Linyi Taihao International Trading received?
Linyi Taihao International Trading 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 Linyi Taihao International Trading come from?
All FDA import refusal data for Linyi Taihao International Trading 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.