Shensha Industrial Co Ltd (Shantou)
⚠️ Moderate Risk
FEI: 3006480219 • Shantou, Guangdong • CHINA
FEI Number
3006480219
Location
Shantou, Guangdong
Country
CHINAAddress
301 4th Buildingcitiplace Jinsha Road, , Shantou, Guangdong, 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).
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 Shensha Industrial Co Ltd (Shantou)'s FDA import refusal history?
Shensha Industrial Co Ltd (Shantou) (FEI: 3006480219) has 1 FDA import refusal record(s) in our database, spanning from 11/4/2008 to 11/4/2008.
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. Shensha Industrial Co Ltd (Shantou)'s FEI number is 3006480219.
What types of violations has Shensha Industrial Co Ltd (Shantou) received?
Shensha Industrial Co Ltd (Shantou) 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 Shensha Industrial Co Ltd (Shantou) come from?
All FDA import refusal data for Shensha Industrial Co Ltd (Shantou) 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.