SINOMEDI INTERNATIONAL CO., LTD.
⚠️ Moderate Risk
FEI: 3007303665 • Chengdu, Sichuan • CHINA
FEI Number
3007303665
Location
Chengdu, Sichuan
Country
CHINAAddress
507 Yingmenkou Road, , Chengdu, Sichuan, 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).
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).
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
Frequently Asked Questions
What is SINOMEDI INTERNATIONAL CO., LTD.'s FDA import refusal history?
SINOMEDI INTERNATIONAL CO., LTD. (FEI: 3007303665) has 2 FDA import refusal record(s) in our database, spanning from 4/15/2008 to 8/11/2008.
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. SINOMEDI INTERNATIONAL CO., LTD.'s FEI number is 3007303665.
What types of violations has SINOMEDI INTERNATIONAL CO., LTD. received?
SINOMEDI INTERNATIONAL 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 SINOMEDI INTERNATIONAL CO., LTD. come from?
All FDA import refusal data for SINOMEDI INTERNATIONAL 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.