Weterm International (shenzhen) Co., Limited
⚠️ Moderate Risk
FEI: 3008398106 • Guangdong • CHINA
FEI Number
3008398106
Location
Guangdong
Country
CHINAAddress
B Building, Anle Industrial Zone, Baoan 43th District, Shenzhen Province, 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
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).
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 Weterm International (shenzhen) Co., Limited's FDA import refusal history?
Weterm International (shenzhen) Co., Limited (FEI: 3008398106) has 2 FDA import refusal record(s) in our database, spanning from 8/23/2010 to 8/23/2010.
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. Weterm International (shenzhen) Co., Limited's FEI number is 3008398106.
What types of violations has Weterm International (shenzhen) Co., Limited received?
Weterm International (shenzhen) Co., Limited 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 Weterm International (shenzhen) Co., Limited come from?
All FDA import refusal data for Weterm International (shenzhen) Co., Limited 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.