Shenzhen Itsuwa Technology Co., Ltd.
⚠️ High Risk
FEI: 3012688121 • Shenzhen, Guangdong • CHINA
FEI Number
3012688121
Location
Shenzhen, Guangdong
Country
CHINAAddress
Zone B, 3/F, Bldg.2&4/F, Bldg.6, Yangbei Industrial Zone Phase 3, Huangtian, Xixiang Street, Baoan, Shenzhen, Guangdong, China
High Risk
FDA Import Risk Assessment
This firm has a significant history of FDA import refusals with notable violations.
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
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 |
|---|---|---|---|
| 9/30/2022 | 66VBQ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/30/2022 | 66VBQ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/30/2022 | 66VBQ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/30/2022 | 66VBQ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/30/2022 | 66VBQ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/30/2022 | 66VBQ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/30/2022 | 66VBQ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
| 9/30/2022 | 66VBQ99MISCELLANEOUS PATENT MEDICINES, ETC. | 75UNAPPROVED | Division of West Coast Imports (DWCI) |
Frequently Asked Questions
What is Shenzhen Itsuwa Technology Co., Ltd.'s FDA import refusal history?
Shenzhen Itsuwa Technology Co., Ltd. (FEI: 3012688121) has 8 FDA import refusal record(s) in our database, spanning from 9/30/2022 to 9/30/2022.
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. Shenzhen Itsuwa Technology Co., Ltd.'s FEI number is 3012688121.
What types of violations has Shenzhen Itsuwa Technology Co., Ltd. received?
Shenzhen Itsuwa Technology Co., Ltd. has been cited for 1 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 Shenzhen Itsuwa Technology Co., Ltd. come from?
All FDA import refusal data for Shenzhen Itsuwa Technology 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.