Shian Jia Meei Enterprise Co., Ltd.
⚠️ High Risk
FEI: 3006395305 • Tainan City • TAIWAN
FEI Number
3006395305
Location
Tainan City
Country
TAIWANAddress
Pei Hua Village, Kuang Miao District, No. 5 Huayuan 2nd St.; Guanmiao Dist., Tainan City, , Taiwan
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
DEVICEGMPS
The article is subject to refusal of admission pursuant to Section 801(a)(1) in that the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of Section 520(f)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) or a condition prescribed by an order under section 520(f)(2) of the FD&C Act.
Refusal History
| Date | Product | Violations | Division |
|---|---|---|---|
| 7/30/2025 | 89IRTPAD, HEATING, POWERED | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 7/30/2025 | 89IRTPAD, HEATING, POWERED | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 7/30/2025 | 89IRTPAD, HEATING, POWERED | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 7/30/2025 | 89IRTPAD, HEATING, POWERED | 2780DEVICEGMPS | Division of West Coast Imports (DWCI) |
| 7/30/2025 | 89IRTPAD, HEATING, POWERED | 2780DEVICEGMPS | Division of West Coast Imports (DWCI) |
| 7/30/2025 | 89IRTPAD, HEATING, POWERED | 2780DEVICEGMPS | Division of West Coast Imports (DWCI) |
| 7/23/2025 | 89IRTPAD, HEATING, POWERED | 2780DEVICEGMPS | Division of Southeast Imports (DSEI) |
| 7/10/2025 | 89IRTPAD, HEATING, POWERED | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
| 7/1/2025 | 89IRTPAD, HEATING, POWERED | 2780DEVICEGMPS | Division of Northern Border Imports (DNBI) |
Frequently Asked Questions
What is Shian Jia Meei Enterprise Co., Ltd.'s FDA import refusal history?
Shian Jia Meei Enterprise Co., Ltd. (FEI: 3006395305) has 9 FDA import refusal record(s) in our database, spanning from 7/1/2025 to 7/30/2025.
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. Shian Jia Meei Enterprise Co., Ltd.'s FEI number is 3006395305.
What types of violations has Shian Jia Meei Enterprise Co., Ltd. received?
Shian Jia Meei Enterprise 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 Shian Jia Meei Enterprise Co., Ltd. come from?
All FDA import refusal data for Shian Jia Meei Enterprise 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.